Annual Report

Dokumendiregister	Sotsiaalministeerium
Viit	1.4-2/1344-1
Registreeritud	22.05.2026
Sünkroonitud	25.05.2026
Liik	Sissetulev kiri
Funktsioon	1.4 EL otsustusprotsess ja rahvusvaheline koostöö
Sari	1.4-2 Rahvusvahelise koostöö korraldamisega seotud kirjavahetus (Arhiiviväärtuslik)
Toimik	1.4-2/2026
Juurdepääsupiirang	Avalik
Adressaat	European Commission
Saabumis/saatmisviis	European Commission
Vastutaja	Jelizaveta Ter-Minasjan (Sotsiaalministeerium, Kantsleri vastutusvaldkond, Terviseala asekantsleri vastutusvaldkond, Tervishoiuteenuste osakond)
Originaal	Ava uues aknas

Failid

E-kiri.eml

Final Results SARE Blood 2025 (data 2024).pdf

SARE Blood 2025 (data 2024) Annual Summary Report.pdf

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Final Results SARE Blood 2025 (data 2024).pdf

SARE Blood 2025 (data 2024) Annual Summary Report.pdf

E-kiri.eml

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.

Dear competent authorities for blood and blood components,

Please find attached the SARE Blood 2025 (data 2024) Report, prepared by EDQM, together with a presentation containing the results, for your final review (deadline for comments: 5 June 2026).

If you have any questions, please send them to [email protected].

We would also like to take this opportunity to remind you that SARE 2026 (data 2025) is open for submission by the competent authorities until 30 June 2026.

If your authority experiences any difficulties in accessing the platform, please inform us.

Best wishes,

MIRKO CLAUS

Policy Officer, on behalf of the SoHO team

---

European Commission
DG SANTE (Health and Food Safety)

Unit D2 – Medical Products: quality, safety, innovation

Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium
https://health.ec.europa.eu/blood-tissues-cells-and-organs_en

From: EDQM SARE-BLOOD <[email protected]>
Sent: Wednesday, May 20, 2026 2:11 PM
To: SANTE SOHO <[email protected]>; SANTE DL SOHO <[email protected]>
Cc: BUSIC Mirela <[email protected]>; EDQM SARE-BLOOD <[email protected]>
Subject: SARE Blood 2025 (data 2024) Annual Summary Report
Importance: High

Dear colleagues,

Hope you are well.

Please find attached the SARE Blood 2025 (data 2024) Report to be shared with the MS for their final review.

I am also attaching the ppt with the final results used in the report.

Please let me know if you have any questions or doubts.

[…]

Kind regards,

Daniela SILVA

Senior Project Officer

Intergovernmental Committees and Networks Department (ICND)
European Directorate for the Quality of Medicines & HealthCare (EDQM)

Council of Europe

Final Results SARE Blood 2025 (data 2024).pdf

THE EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM)

2025 SARE Exercise (2024 data)

SARE Reporting for Blood and Blood Components

SoHO Standards Section, Intergovernmental Committees and Networks Department (ICND)

EDQM, Council of Europe

2025 SARE Exercise (2024 data)

DATA COLLECTED from 28* Countries: AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, EL, IS, IE, IT, LV, LT, LU, NL, NO, PL, PT, RO, SK, SI, ES, SE and UK (Northern Ireland)

• 2022 SARE exercise: 30 reporting countries • 2023 SARE exercise: 30 reporting countries • 2024 SARE exercise: 30 reporting countries

*25 Member States + 3 Non-Member States

Note: HU, LI and MT didn’t submit data for this current exercise

2025 SARE Exercise (2024 data)

Table of Contents

• Activity Dataset

• SAR (IL 2-3) in Recipients

• SAE

• SAR in Donors

• Annexes

2025 SARE Exercise (2024 data)

Highlights 2025

(infographic made in CANVA)

2025 SARE Exercise (2024 data)

Activity Dataset

o Total Number of Units Issued (sum of number of units for each type of blood component)

o Total Number of Units Transfused (sum of number of units for each type of blood component)

o Total Number of Recipients Transfused (regardless of type of blood component)

o Total Number of Units Processed

o Total Number of Whole Blood Collections o Total Number of Apheresis Collections

2025 SARE Exercise (2024 data)

Activity Dataset

- Annual trends (2021 – 2024) - Geographic distribution - Overview of volume of activity - Country-specific trends (2023 vs. 2024)

2025 SARE Exercise (2024 data)

Annual Trends Whole Blood Donation/Collection Rate (median) (per 1 000 population)

n 28 26 26 26

population as 1st January Y+1, https://ec.europa.eu/eurostat/

2025 SARE Exercise (2024 data)

Annual Trends Apheresis Donation Rate (median) (per 1 000 population)

n 28 26 25 25

population as 1st January Y+1, https://ec.europa.eu/eurostat/

2025 SARE Exercise (2024 data)

Annual Trends Rates of units issued, transfused and processed (median) (per 1 000 population)

n(issued) 30 30 30 28

n(processed) 28 27 26 28

n(transfused) 26 24 23 23

population as 1st January Y+1, https://ec.europa.eu/eurostat/

2025 SARE Exercise (2024 data)

Annual Trends Rate of Recipients transfused (median)

(per 1 000 population)

(regardless of type of BC)

n 16 18 17 17

population as 1st January Y+1, https://ec.europa.eu/eurostat/

2025 SARE Exercise (2024 data)

Annual Trends Transfusion Rate (median) by Type of BC pmp

Red Blood Cells (RBC) Platelets and Plasma

n 25 24 23 23

BC= blood component pmp= per 1 million population population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note: for plasma, n includes countries that reported zero units transfused

2025 SARE Exercise (2024 data)

Annual Trends Transfusion Rate (median) by Type of BC pmp

Whole Blood

population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note: n includes countries that reported zero whole blood units transfused

2025 SARE Exercise (2024 data)

WB Collection Rates (per 1 000 population)

population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note: LU and SK reported N/A

2025 SARE Exercise (2024 data)

Apheresis Collection Rates (per 1 000 population)

population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note: LU, SK and SE reported N/A

2025 SARE Exercise (2024 data)

Issuance Rates of blood/BC units (per 1 000 population)

population as 1st January Y+1, https://ec.europa.eu/eurostat/

2025 SARE Exercise (2024 data)

Transfusion Rates of blood/BC units (per 1 000 population)

population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note1: new rate reported for SK; significant increase for RO in comparison with 2023 (rate 23) Note2: FI, LV, LT, PL and SI reported N/A

2025 SARE Exercise (2024 data)

Recipient Rate (per 1 000 population) (regardless of type of BC)

population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note1: new rate reported for RO Note2: AT, FI, DE, IE, LV, LT, NL, NO, PL, SK and SI reported N/A

Comment NL: “66/79 hospitals provided numbers of recipients per type of blood component. Fewer hospitals 61/79 = 77% (see general numbers) provided total number of recipients (irrespective of the type of blood component); that is why we do not give a total for this.”

2025 SARE Exercise (2024 data)

Activity Dataset by Type of BC Absolute numbers; comparative data 2023 - 2024

Total Number of Units Issued

2023 2024 %

Change

RBC 15 933 863 15 413 314 -3

Platelets 2 561 256 2 430 261 -5

Plasma 2 324 231 2 619 750 +13

WB 4 669 3 894 -17

Total Number of Units Transfused

2023 2024 %

Change

RBC 12 565 950 12 758 561 +2

Platelets 1 936 030 1 992 202 +3

Plasma 1 707 318 1 724 288 +1

WB 3 936 3 361 -15

n (RBC) 30 28

n (Platelets) 30 28

n (Plasma) 30 (including 2

reporting zero)

28 (including 2

reporting zero)

n (WB) 25 (including 12

reporting zero)

22 (including 7

reporting zero)

n = number of countries reporting

n (RBC) 23 23

n (Platelets) 23 23

n (Plasma) 23 (including 2

reporting zero)

24 (including 2

reporting zero)

n (WB) 22 (including 12

reporting zero)

19 (including 7

reporting zero)

Total Number of Recipients transfused

2023 2024 %

Change

RBC 2 202 858 2 320 512 +5

Platelets 266 131 294 558 +11

Plasma 210 292 249 752 +19

WB 1 480 1 547 +5

n (RBC) 18 18

n (Platelets) 18 18

n (Plasma) 18 (including 2

reporting zero)

19 (including 2

reporting zero)

n (WB) 18 (including 12

reporting zero)

17 (including 7

reporting zero)

2025 SARE Exercise (2024 data)

Transfusion Rates (median) pmp by Type of BC comparative data 2023 - 2024

Type of BC 2023

(median rate pmp)

2024 (median rate

pmp)

RBC 29 187 27 881

Platelets 4 778 4 530

Plasma 3 585 3 493

Whole Blood 0.0 0.9

2025 SARE Exercise (2024 data)

Transfusion Rates - RBC (pmp); comparative data 2023 - 2024

2025 SARE Exercise (2024 data)

Transfusion Rates - Platelets (pmp); comparative data 2023 - 2024

2025 SARE Exercise (2024 data)

Transfusion Rates - Plasma (pmp); comparative data 2023 - 2024

2025 SARE Exercise (2024 data)

Transfusion Rates – Whole Blood (pmp); comparative data 2023 - 2024

Comment CY: “We do not transfuse whole blood units. This year, however, there was one case of autologous blood transfusion ( the blood was collected, tested and then transfused).”

Note: in 2023, AT, HR, CY, DE, EL, IS, IE, LV, LI, LU, NL and UK(NI) reported 0 units and consequently a zero rate (not shown above). In 2024, AT, BE, HR, CY, EL, IS, NL and UK(NI) reported 0 units of WB transfused and consequently a zero rate (not shown above).

2025 SARE Exercise (2024 data)

Serious Adverse Reactions (in Recipients)

27 Countries: AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, EL, IE, IT, LV, LT, LU, NL, NO, PL, PT, RO, SK, SI, ES, SE and UK(NI) (No SAR from IS)

Denominator used: o Total Number of Units Transfused (sum of number of units for each type of BC)

2025 SARE Exercise (2024 data)

SAR (IL 2-3) (Mandatory)

- Annual trends (2021 – 2024) - Geographic distribution

- Annual trends (2021 – 2024) by type of BC - Country specific trends (2023 vs. 2024) by type of BC - Overview of SAR and fatalities by type of BC

- Annual trends (2021 – 2024) by type of reaction - Overview of SAR and fatalities by type of reaction

- Fatalities examples

2025 SARE Exercise (2024 data)

Annual Trends SAR (IL 2-3)Incidence (total and median) (per 100 000 units transfused)

n 26 24 24 23

Note1: two complementary metrics: (1) the total SAR (IL 2–3) incidence per 100 000 units of blood/BC transfused, and (2) the median of country-specific SAR (IL 2–3) incidence rates (per 100 000 units transfused) across all reporting countries. Total SAR (IL 2-3) is calculated using all reported cases as the numerator and the sum of all reported units transfused (including countries reporting zero SAR) as the denominator. Countries not reporting denominator data but reporting SAR contribute to the numerator but not the denominator. Please refer to the denominator completeness table (Annex) for coverage details.

Note2: only countries (n) that reported both SAR (IL 2-3) cases (including zero) and the corresponding number of units of blood/BC transfused were included in the median per-country incidence calculations

2025 SARE Exercise (2024 data)

SAR (IL 2-3) Incidence rates (per 100 000 units transfused)

Note1: the following countries reported SAR- FI (13), LV (1), LT (1), PL (73) and SI (13) but didn’t provide number of units transfused so incidence couldn’t be calculated Note2: significant increase for LU and IE in comparison with 2023 (rate 0 and 19, respectively) moderate increase for NL, HR and SE (rate 12, 3 and 2 respectively) rates decreased for AT, IT, PT and ES

2025 SARE Exercise (2024 data)

Annual Trends Median SAR (IL 2-3) Incidence per country by Type of BC (per 100 000 units transfused)

n(platelets) 26 24 23 23

n(plasma) 25 21 21 22

n(RBC) 25 24 23 23

Note1: only countries that reported both SAR (IL 2-3) cases (including zero) and the corresponding number of units transfused per BC were included in the median per- country incidence calculations Note 2: median SAR incidence in WB is not shown above as only one country reported throughout the period (2021: 2 cases; 2022: 0; 2023: 1 case; 2024: 2 cases).

2025 SARE Exercise (2024 data)

Annual Trends Fatalities (IL 2-3) by Type of BC

MTOC = more than one blood component transfused

Absolute numbers

2025 SARE Exercise (2024 data)

SAR (IL 2-3) Incidenceratesby Type of BC (per 100 000 units transfused) Country

RBC

2023 2024 Absolute change

Austria (AT) 20 12 -8

Belgium (BE) 4 5 +1

Bulgaria (BG) 1 0 -1

Croatia (HR) 3 5 +2

Czechia (CZ) 2 2 0

Denmark (DK) 2 1 -1

Estonia (EE) 0 2 +2

France (FR) 2 3 +1

Germany (DE) 5 6 +1

Greece (EL) 26 12 -14

Ireland (IE) 18 43 +25

Italy (IT) 11 8 -3

Luxembourg (LU) 0 30 +30

Netherlands (NL) 9 14 +5

Norway (NO) 9 4 -5

Portugal (PT) 5 3 -2

Romania (RO) 1 1 0

Slovakia (SK) * 19 -

Spain (ES) 6 4 -2

Sweden (SE) 2 4 +2

United Kingdom (NI) 23 5 -18

Potential real-concern signals

True improvements

Platelets

2023 2024 Absolute change

22 12 -10

12 13 +1

0 0 0

3 9 +6

2 0 -2

6 7 +1

0 0 0

9 8 -1

11 15 +4

26 58 +32

23 79 +56

40 35 -5

0 34 +34

17 17 0

13 28 +15

12 6 -6

1 1 0

* 58 -

12 10 -2

4 2 -2

45 30 -15

Plasma

2023 2024 Absolute change

48 0 -48

5 6 +1

0 0 0

0 3 +3

10 5 -5

3 6 +3

0 0 0

14 10 -4

5 6 +1

20 36 +16

- - -

11 8 -3

0 0 0

7 7 0

0 0 0

1 1 0

* 28 -

12 5 -7

0 7 +7

50 0 -50

* denominator missing

comparative data 2023 - 2024

Note 1: CY and IS reported zero SAR across the different types of BC in both 2023 and 2024 (not shown above). Note 2: SAR incidence rates in WB not shown above (2023 (IT): 1 SAR reported; 2024 (NO): 2 SAR reported). Note 3: *in 2023, SK reported N/A for number of units transfused so incidence could not be calculated. Note 4: highlighted in red are changes that represent a potential real concern. These countries show multiple SARs (not just 1–2), large transfusion denominators (so rates are stable), sharp increases beyond what small-number variation can explain. Highlighted in green are true improvements not strongly influenced by small denominators or low SAR counts.

2025 SARE Exercise (2024 data)

SAR (IL 2-3) by Type of BC (for countries which also reported SAR but are missing denominator data)

Country 2023 2024 Absolute change

Finland (FI) 4 7 +3

Latvia (LV) 1 0 -1

Lithuania (LT) 0 1 +1

Poland (PL) 53 54 +1

Slovenia (SI) 6 6 0

RBC Platelets

Plasma

Country 2023 2024 Absolute change

Finland (FI) 0 6 +6

Latvia (LV) 0 0 0

Lithuania (LT) 0 0 0

Poland (PL) 11 6 -5

Slovenia (SI) 3 4 +1

Country 2023 2024 Absolute change

Finland (FI) 0 - -

Latvia (LV) 1 0 -1

Lithuania (LT) 0 0 0

Poland (PL) 9 9 0

Slovenia (SI) 1 3 +2

comparative data 2023 - 2024

2025 SARE Exercise (2024 data)

Absolute numbers; comparative data 2023 - 2024

Total Number of SAR (IL 2-3)

2023 2024 %

Change

RBC 972 821 -16

Platelets 312 334 +7

Plasma 143 142 -1

MTOC 62 61 -2

WB 1 2 (absolute

change +1)

TOTAL 1 490 1 360 -9

Total SAR (IL 2-3) and Fatalities (IL 2-3) by Type of BC

n (RBC) 24 24

n (Platelets) 21 21

n (Plasma) 16 15

n (MTOC) 12 10

n (WB) 1 1

Total Number of Fatalities (IL 2-3)

2023 2024 Absolute Change

RBC 17 7 -10

Platelets 2 2 0

Plasma 0 0 0

MTOC 2 2 0

WB 0 0 0

TOTAL 21 11 -10

n (RBC) 9 4

n (Platelets) 2 1

n (Plasma) 0 0

n (MTOC) 1 2

n (WB) 0 0

2025 SARE Exercise (2024 data)

Absolute numbers

TotalSAR (IL 2-3) by Type of BC

Note1: also 2 SAR for Whole Blood from NO were reported Note2: BG, CY and IS reported zero SAR (not shown above)

2025 SARE Exercise (2024 data)

Types of reportable transfusion reactions

Immunologically related SAR Cardiovascular and metabolic

problems

Transfusion-

transmitted infection

(TTI)

• Transfusion-related acute lung injury (TRALI)

• Anaphylaxis/hypersensitivity

• Febrile non-haemolytic transfusion reaction

(FNHTR)

• Immunological haemolysis

(due to ABO incompatibility/due to other

alloantibody)

• Post-transfusion purpura (PTP)

• Transfusion-associated graft-versus-host

disease (Ta-GvHD)

---------------------------------------------------------------------------------

Non-immunological haemolysis

• Transfusion-associated

cardiovascular overload

(TACO)

• Hypotensive transfusion

reaction

• Transfusion-associated

dyspnoea (TAD)

• Bacterial (TTBI)

• Viral (TTVI)

o HBV, HCV, HIV-

1/2, other

• Parasitical (TTPI)

o malaria, other

• Fungal (TTFI)

• Prion (TTPRI)

Other (reactions which do not meet the criteria for a defined category)

2025 SARE Exercise (2024 data)

Annual Trends SAR (IL 2-3) by main Types of Reaction

Percentage (%) of total SAR (IL 2-3)

Main Types of Reaction 2021 2022 2023 2024

Other 29.9 27.0 11.7 10.4

FNHTR 24.2 23.0 24.6 26.1

Anaphylaxis/ hypersensitivity 15.7 18.6 25.4 25.7

TACO 13.4 13.2 14.4 16.7

Immunological haemolysis 8.4 9.0 13.3 10.4

TAD 3.0 2.6 3.1 3.5

TRALI 2.7 3.6 3.8 3.8

2025 SARE Exercise (2024 data)

Annual Trends Fatalities (IL 2-3) by Type of Reaction Absolute numbers

2025 SARE Exercise (2024 data)

SAR (IL 2-3) by Type of Reaction Absolute numbers; comparative data 2023 - 2024

Note: for both 2023 and 2024, no data was reported for the following types of reaction: Transfusion associated graft versus host disease and Transfusion- transmitted fungal and prion infection

Comment DE: “Please note that six cases listed in the category "Immunological haemolysis due to other alloantibody" refer to Autoimmunhaemolysis triggered by the transfusion (Imputability level 2: 4 cases; Imputability level 3: 2 cases).”

2025 SARE Exercise (2024 data)

Distribution of SAR (IL 2-3) classified as ‘Other’ Absolute numbers

Comment DE: “Each year a couple amount of reactions are reported with the term "other". Most of these reactions are symptoms due to another medical condition which coincidentally happened in a timely relationship to the transfusion. These are assessed as unlikely and therefore not reported. In some cases the reported symptoms might be attributable to allergic type reactions or febrile reactions but are not diagnosed as such by the reporters. These cases are assessed as possible and therefore reported.”

2025 SARE Exercise (2024 data)

SAR (IL 2-3) by Type of Reaction and by Type of BC (excludes fatalities (IL 2-3))

Top 5 Reaction Types

Anaphylaxis/hypersensitivity

FNHTR

TACO

Immunological haemolysis

Other

Immunological Haemolysis a) due to ABO incompatibility b) due to other alloantibody

17 19

6 8

7 7

a) 1 b) 2

a) 3 b) 1

7 7

n (Anaphylaxis/hypersensitivity) 0 1

n (FNHTR) 0 0

n (TACO) 1 0

n (Immunological haemolysis) 0 0

n (Other) 0 1

Platelets

2023 2024 Absolute Change

140 135 -5

71 110 +39

12 10 -2

a) 1 b) 10

a) 3 b) 1

a) +2 b) -9

52 34 -18

Absolute numbers; comparative data 2023 - 2024

RBC

2023 2024 Absolute Change

133 100 -33

276 224 -52

170 200 +30

a) 65 b) 108

a) 62 b) 68

a) -3 b) -40

103 83 -20

15 16

11 15

20 19

a) 14 b) 20

a) 11 b) 17

10 14

2023 2024 Absolute Change

0 1 +1

0 0 0

1 0 -1

0 0 0

0 1 +1

Comment DE: “Please note that seven cases listed in the category "Immunological haemolysis due to other alloantibody" refer to Autoimmunhaemolysis triggered by the transfusion (Imputability level 1: 1 case; Imputability level 2: 4 cases; Imputability level 3: 2 cases).” “Each year a couple amount of reactions are reported with the term "other". Most of these reactions are symptoms due to another medical condition which coincidentally happened in a timely relationship to the transfusion. These are assessed as unlikely and therefore not reported. In some cases the reported symptoms might be attributable to allergic type reactions or febrile reactions but are not diagnosed as such by the reporters. These cases are assessed as possible and therefore reported.”

2025 SARE Exercise (2024 data)

SAR (IL 2-3) by Type of Reaction and by Type of BC cont. (excludes fatalities (IL 2-3))

Top 5 Reaction Types

Plasma

2023 2024 Absolute Change

Anaphylaxis/hypersensitivity 89 91 +2

FNHTR 15 14 -1

TACO 9 6 -3

Immunological haemolysis a) 3 a) 1 -2

Other 14 17 +3

Immunological Haemolysis a) due to ABO incompatibility b) due to other alloantibody

n (Anaphylaxis/hypersensitivity) 14 14

n (FNHTR) 4 3

n (TACO) 5 4

n (Immunological haemolysis) a) 1 a) 1

n (Other) 4 3

6 6

3 4

7 6

b) 2 b)1

4 3

MTOC

2023 2024 Absolute Change

16 21 +5

5 7 +2

19 9 -10

b) 2 b) 4 +2

4 5 +1

Absolute numbers; comparative data 2023 - 2024

Note: Also, for Whole Blood, in 2024, 1 anaphylaxis/hypersensitivity, 1 Other: Hyperkalemia (vs 2023: 1 TACO)

Comment NO: (2 Whole Blood SAR) “The hyperkalemic reaction was life-threatening and let to a cardiac arrest. This incidence will be reported on in a scientific publication, hopefully within a month or two. The anaphylactic episode will also be mentioned in this publication.”

2025 SARE Exercise (2024 data)

SAR (IL 2-3) - TTI

n (TTBI) 7 4

n (TTVI) 3 3

n (TTPI) 1 0

Type of TTI 2023 2024 Absolute Change

TTBI 15 6 -9

TTVI 4 8 +4

TTPI 1 0 -1

TOTAL 20 14 -6

TT- Transfusion Transmitted

Absolute numbers; comparative data 2023 - 2024

Type of TTI

RBC

2023 2024 Absolute Change

TTBI 7 1 -6

TTVI 3 2 -1

TTPI 1 0 -1

TOTAL 11 3 -8

Platelets

2023 2024 Absolute Change

8 5 -3

0 5 +5

8 10 +2

MTOC

2023 2024 Absolute Change

0 1 +1

0 1 +1

Plasma

2023 2024 Absolute Change

1 0 -1

1 0 -1

Note 1: zero TTFI and TTPRI cases reported in both 2023 and 2024. Note 2: zero TTIs reported in WB in both 2023 and 2024.

2025 SARE Exercise (2024 data)

SAR (IL 2-3) - TTI

Country (#SAR) RBC Platelets

France (1) (1) Staphylococcus ureilyticus

Germany (3) (1) E. coli (2) Bacillus cereus

Greece (1) (1) N/A

Spain (1) (1) E. coli

The exact infectious pathogen was provided for 5 (83%) out of 6 SAR- TTBI (in

2023: 47%)

TTBI

Country (#SAR) RBC Platelets MTOC

Finland (4) (1) Other: HEV (3) Other: HEV

France (1) (1) Parvo-B19

Germany (3) (1) Parvo-B19 (1) Parvo-B19 (1) Parvo-B19

TTVI

Note: Spain platelets case occurred in 2023, but investigation finalized in 2024

2025 SARE Exercise (2024 data)

Total Fatalities (IL 2-3) by Type of Reaction, Type of BC and Country

Fatalities (IL 2-3) = 11

5 Countries Reporting: BE, FI, FR, DE, NO

Absolute numbers

Type of Reaction # IL 2 # IL 3

TACO 2

Anaphylaxis/ hypersensitivity 2

Immunological haemolysis due to ABO incompatibility

Other 1

TTBI 1

Immunological haemolysis due to other alloantibody

TRALI 1

Hypotensive transfusion reaction 1

TOTAL 6 5

2025 SARE Exercise (2024 data)

Fatalities (IL 2-3) by Type of Reaction and by Type of BC

Type of Reaction

RBC

2023 2024 Absolute Change

Immunological haemolysis a)5 b)4

a)2 b)1

a)-3 b)-3

TACO 4 1 -3

TRALI 1 0 -1

TTBI 1 0 -1

Anaphylaxis/hypersensitivity 0 1 +1

Hypotensive transfusion reaction

0 1 +1

Other 2 1 -1

Platelets

2023 2024 Absolute Change

2 1 -1

0 1 +1

MTOC

2023 2024 Absolute Change

0 1 +1

2 1 -1

Immunological Haemolysis a) due to ABO incompatibility b) due to other alloantibody

Absolute numbers; comparative data 2023 - 2024

Note: no fatalities (IL 2-3) reported in plasma

2025 SARE Exercise (2024 data)

Fatalities - Reporting requirements

➢ Reporting requirements for fatalities (IL 2-3) in recipients:

• Requirements met (partially or fully) by 11 out of 11 cases (100%)

Common Approach, version 2025: “Concerning reports where a SAR is confirmed to be fatal, any relevant information should be reported in the comments box, such as: (1) a brief description of patient details (if possible: gender, age, initial illness, clinical indications for transfusion, etc.), (2) a brief description of the occurrences that led to the fatality. In the case of a transfusion-transmitted infection, state the pathogen (species) which was demonstrated (3) a list of transfused units of blood/blood components; for each unit, any relevant information regarding the preparation of the implicated component(s) (leucodepletion, apheresis...), (4) the conclusions and follow-up actions (corrective and preventive), if appropriate.”

NEW!

➢ Pathogen stated in 3 out of 3 TTI cases (2 IL1, 1 IL3)

2025 SARE Exercise (2024 data)

Fatalities (IL 2-3) – Examples Type of BC

Type of Reaction

RBC

Anaphylaxis/ hypersensitivit y

2 Patient details: The patient was a 66-year-old man with extensive comorbidities including type II diabetes, hypertension, heart disease with prior aortic valve replacement for endocarditis, previous stroke, COPD, chronic alcoholism, and active smoking. He was admitted for severe gastrointestinal bleeding causing anaemia (Hb 72 g/L), for which one RBC unit was prescribed.

Events leading to the fatality/Investigation: Immediately upon starting the transfusion, within the first millilitre, the patient developed acute airway obstruction with facial edema, macroglossia, and respiratory distress, progressing rapidly to cardiorespiratory arrest despite emergency airway management and rescue tracheostomy. Compatibility testing and donor history revealed no abnormalities, and the patient had been transfused previously without adverse reactions. Post-mortem biomarkers showed histamine >100 nmol/L and tryptase 10.1 µg/L (below 11 µg/L but above the 95th percentile of 8.4 µg/L) which support a severe anaphylactic-like reaction as the likely cause of fatal hypoxia.

Transfused units and component details: Only one unit of leukoreduced packed RBC was transfused, sourced from a regular donor with no medications and no previous adverse reactions reported from other donations.

Root Cause/Conclusions: The fatality is consistent with a probable severe anaphylactic transfusion reaction leading to refractory airway obstruction and hypoxia.

Other (DHTR) 3 Patient details: The patient was a 23-year-old with homozygous sickle cell disease, a history of multiple vaso-occlusive crises, acute chest syndrome, cerebral vasculopathy, cholecystitis, osteomyelitis, and a previous delayed haemolytic transfusion reaction (no antibodies identified). He was receiving hydroxyurea, voxelotor, and had recently completed rituximab therapy; two phenotyped, matched RBC units were transfused before planned stem cell transplantation.

Events leading to the fatality/investigation: From day 5 post-transfusion, the patient developed a vaso-occlusive crisis with laboratory signs of haemolysis (no new antibodies identified), then on day 6 experienced renal failure with acidosis and severe hyperkalaemia, respiratory failure with bilateral pulmonary involvement, and cardiogenic shock, with worsening haemolysis and renal failure and Hb falling to 50 g/L. On day 7, a sudden haemodynamic collapse occurred with severe hypotension; echocardiography showed acute pulmonary heart with LV systolic failure, and the patient died in multivisceral failure despite maximal resuscitation. No new alloantibodies were detected, and compatibility testing did not reveal abnormalities.

Transfused units and component details: Two units of phenotyped, antigen-matched, leukoreduced RBCs were transfused, each preceded by a blood exchange.

Root Cause/Conclusions: The clinical course is consistent with a severe delayed haemolytic transfusion reaction (DHTR) with hyperhaemolysis, complicated by renal failure, acute chest syndrome–like manifestations, right-heart failure, and multivisceral collapse.

2025 SARE Exercise (2024 data)

Fatalities (IL 2-3) – Examples

Type of BC

Type of Reaction

RBC TACO 2

Patient (M, 84 years): HISTORY: - Patient known by palliative support team: AML (Acute Myeloid Leukemia) + aortic valve stenosis.

SYMPTOMS REACTION: - General malaise (palliative; AML) - Hypertension: before transfusion 162/66, after 15' 173/81, stop transfusion at 12:21 213/86 - Temp: before transfusion 37°C, after 15' 36.9°C, stop transfusion 37.8°C + SHIVERING - Shivering fever again in the evening: temp at 18:00: 38.2°C and 19:25 38.4°C - At 20:00: oxygen administration (sat 87%) - At 20:45: patient deceased

DIAGNOSIS: - Still haemolysis? Acute pulmonary edema? Due to underlying disease?

Type of BC

Type of Reaction

RBC Hypotensive transfusion reaction

2 Female (80 years old) had acute bleeding and also suspected to have septic shock. Patient died less than 24 hours from the transfusion. Patient's IgA levels were found to be normal. Microbial culture was performed on the remains of the red blood cell unit and there was no growth. It is unlikely that the patient's symptoms were due to contaminated RBC unit.

2025 SARE Exercise (2024 data)

Serious Adverse Events

25 Countries: AT, BE, HR, CY, CZ, DK, EE, FI, FR, DE, EL, IE, IT, LV, LU, NL, NO, PL, PT, RO, SK, SI, ES, SE and UK(NI) (No SAE from BG, IS and LT)

SAE=4 764

(2023: 2 294; n=26; 108% increase in 2024 primarily driven by RO’s new data)

Denominator used: o Total Number of Units Processed o 24.4 million (2023: 23.7 million)

2025 SARE Exercise (2024 data)

Serious Adverse Events

- Annual trends (2021 – 2024) - Geographic distribution - Country specific trends (2023 vs. 2024) - Overview of SAE by activity step - Annual trends (2021 – 2024) by specification/type of event - Overview of SAE by type of event

2025 SARE Exercise (2024 data)

Annual Trends SAE Incidence(total and median) (per 100 000 units processed)

n 28 26 26 28

Note1: two complementary metrics: (1) the total SAE incidence per 100 000 units of blood/BC processed, and (2) the median of country-specific SAE incidence rates (per 100 000 units processed) across all reporting countries. Total SAE is calculated using all reported cases as the numerator and the sum of all reported units processed (including countries reporting zero SAE) as the denominator. Countries not reporting denominator data but reporting SAE contribute to the numerator but not the denominator. Please refer to the denominator completeness table (Annex) for coverage details.

Note2: only countries that reported both SAE cases (including zero) and the number of units processed were included in the median per-country SAE incidence calculations

2025 SARE Exercise (2024 data)

SAE Incidence rates (per 100 000 units processed)

Comment RO: “In 2023, there were limitations in our reporting system that led to underreporting or incomplete documentation of events. For this reason, “N/A” was indicated for that year. Starting in 2024, we implemented a revised SAE reporting protocol, along with additional training sessions for personnel involved in the identification and reporting of adverse events. The reporting criteria have been broadened to include cases previously considered minor or ambiguous, in alignment with updated haemovigilance recommendations.” Comment EL: “Due to the centralization of blood components process in the province of Attica, which began in April 2024 at the National Blood Centre (EKEA), no production data has been submitted beyond the first quarter of 2024 in the haemovigilance department of EODY. This accounts for the lower figures.”

2025 SARE Exercise (2024 data)

SAE Incidence rates (per 100 000 units processed); comparative data 2023 - 2024

2025 SARE Exercise (2024 data)

Total SAE by country Absolute numbers

Note: for visualization purposes, RO (3 194) value is not shown above

Comment EL: “Due to the centralization of blood components process in the province of Attica, which began in April 2024 at the National Blood Centre (EKEA), no production data has been submitted beyond the first quarter of 2024 in the haemovigilance department of EODY. This accounts for the lower figures.”

2025 SARE Exercise (2024 data)

SAE by Activity Step (Category)

(Percentage Distribution) Activity Step

2023 position

# SAE 2024 (+/- 2023)

Storage 2 1 987 (+1 621)

Whole blood collection 4= 812 (+621)

Processing 7 715 (+620)

Testing 5 334 (+196)

Donor selection 4= 241 (+55)

Other 1 218 (-622)

Issue 3 206 (+1)

Component selection 6 84 (-25)

Distribution 9= 79 (+21)

Compatibility testing/Cross matching

8 44 (-20)

Apheresis collection 9= 44 (+2)

TOTAL - 4 764 (+2 470)

Note1:the category Other refers, as per the Common Approach, to any other activity or parameter in the process that can affect the quality and safety of the component that may harm a patient. Any entry stating “Other” as well as free text was considered “Other” (for more details see the next slide) Note2: abbreviations: Component selection (BE or HBB activity step), Compatibility testing/Cross-matching (BE or HBB activity step) and Issue (BE or HBB activity step)

Comment NL: “Whether it was a whole blood or apheresis collection is not clear in these 89 whole blood collection cases.”

2025 SARE Exercise (2024 data)

SAE classified by Activity Step ‘Other’ - explained Absolute numbers

2025 SARE Exercise (2024 data)

SAE classified by Activity Step ‘Other’ vs Defined Steps by country

(Percentage Distribution and absolute numbers)

‘Other’ Proportion (%)

Country 2023 2024 Trend

Belgium (BE) 89 1

Cyprus (CY) 15 0

Czechia (CZ) 0 38 NEW

Finland (FI) 0 14 NEW

France (FR) 41 38

Germany (DE) 60 0

Greece (EL) 15 14

Ireland (IE) 21 29

Italy (IT) 40 0

Norway (NO) 1 0

Poland (PL) 40 0

Slovakia (SK) 5 0

Slovenia (SI) 0 50 NEW

Spain (ES) 13 0

United Kingdom (NI) 14 7

Comment DE: “In previous years, all cases of PDI were reported under the category "Other". For 2024, only those PDIs were reported that were either known to the donor at the time of donation but were not reported or not asked about, OR were not yet known at the time of donation but could have affected the quality of donations made further back (e.g. Lyme disease). This time the report was not made under category "Other" but under the categories "whole blood collection" or "apheresis collection". PDIs about acute infections after donation were only reported if the necessary product block or recall was not implemented.”

2025 SARE Exercise (2024 data)

Annual Trends SAE by Type of Event (Specification)

10%

20%

30%

40%

50%

60%

70%

2021 2022 2023 2024

Percentage (%) of total SAE by specification and by year

Human error

Component defect

Equipment failure

System failure

Other

Materials

2025 SARE Exercise (2024 data)

SAE by Type of Event

(Percentage Distribution)

Type of Event 2023

position # SAE 2024

(+/- 2023)

Component defect 3 2 848 (+2 477)

Human error 1 675 (-293)

Equipment failure 2 510 (+113)

Other 4 367 (+55)

System failure 5 229 (0)

Materials 6 135 (+118)

TOTAL - 4 764 (+2 470)

For more details see Annex

Note: abbreviation Other= “Other (please specify)”

2025 SARE Exercise (2024 data)

SAE Activity Step by Type of Event

2025 SARE Exercise (2024 data)

SAE Activity Step ‘Other’ by Type of Event

2025 SARE Exercise (2024 data)

SAE reported as ‘human error’ by type of error

(Percentage Distribution)

Type of error 2023

position # SAE 2024

(+/- 2023)

Incorrect decision or omission following the correct procedure

1 528 (-195)

Other, or no information to assign the available options

2 111 (-109)

Following the wrong procedure 3 36 (+11)

TOTAL - 675 (-293)

2025 SARE Exercise (2024 data)

SAE by Type of Event and by Country (Percentage Distribution)

Note: abbreviation: Other= “Other (please specify)”

2025 SARE Exercise (2024 data)

Serious Adverse Reactions (in Donors)

23 Countries: AT, BE, BG, CY, CZ, DK, EE, FI, FR, DE, EL, IS, IE, IT, LU, NL, NO, PL, PT, RO, SK, SI and SE (No SAR in donors from HR, LV, LT and UK(NI))

SAR= 2 260

(2023: 3 534; n=22; 36% drop in 2024, primarily driven by FR’s scope update)

Denominator used: o Total Number of Whole Blood / Apheresis Collections o 15.7 million (2023: 16.1 million) / 7.6 million (2023: 7.3 million)

Fatalities= 4 (2023: 0)

2025 SARE Exercise (2024 data)

Serious Adverse Reactions (in Donors)

- Geographic distribution - Overview of SAR in WB donors by type of reaction - Overview of SAR in apheresis donors by type of reaction - Fatalities in donors

2025 SARE Exercise (2024 data)

SAR in WB Donors Incidence rates (per 100 000 WB collections)

Note: LT and SK reported N/A for the number of WB collections, so they appear above in dark grey; UK(NI) reported N/A for the number of SAR, also shown above in dark grey.

Comment FR: “(…)from the 2nd of January 2024, the reporting of SAR donors focus on the most serious adverse reactions: only grades 3 (severe) and 4 (death) needs to be reported to the NCA (grades 1 et 2 are notified, traced and analysed at local level of blood establishments). This allows also the harmonization of French data with European and international modalities, for greater comparability of data between countries, particularly EU MS. As a result, the number of SARs in donors reported by France for the 2024 calendar year is significantly lower than that of previous years and cannot be compared given the change in the reporting scope.” Comment SE: “Data is collected on blood collections but is not distinguished between whole blood or apheresis collection. The reported nr of whole blood collection may include an unknown nr of apheresis collections.” Comment EL: “There is a misreporting concerning the grade of severity in the above cases.”

2025 SARE Exercise (2024 data)

SAR in WB Donors Incidence rates (per 100 000 WB collections); comparative data 2023 - 2024

Note 1: for FR, rates are not comparable due to change in the reporting scope (only grade 3 (severe) and grade 4 (death) reported in 2024 vs all grades in 2023). Note 2: LT reported N/A for the number of WB collections in both 2023 and 2024. In 2023, RO reported SAR cases but N/A for the number of WB collections. In 2024, SK reported SAR cases but N/A for the number of WB collections. UK(NI) reported N/A for the number of SAR in both 2023 and 2024.

2025 SARE Exercise (2024 data)

SAR in Apheresis Donors Incidence rates (per 100 000 Apheresis collections)

Note: LT and SK reported N/A for the number of apheresis collections, so they appear above in dark grey; SE and UK(NI) reported N/A for the number of SAR, also shown above in dark grey.

2025 SARE Exercise (2024 data)

SAR in Apheresis Donors Incidence rates (per 100 000 WB collections); comparative data 2023 - 2024

Note 1: for FR, rates are not comparable due to change in the reporting scope (only grade 3 (severe) and grade 4 (death) reported in 2024 vs all grades in 2023). Note 2: LT reported N/A for the number of apheresis collections in both 2023 and 2024. In 2024, SK reported SAR cases but N/A for the number of apheresis collections. SE reported N/A for both the number of SAR and the number of apheresis collections in both 2023 and 2024. UK(NI) reported N/A for the number of SAR in both 2023 and 2024.

2025 SARE Exercise (2024 data)

Total SAR in Donors by country Absolute numbers

Note: UK(NI) reported data N/A.

Comment FR: “(…)from the 2nd of January 2024, the reporting of SAR donors focus on the most serious adverse reactions: only grades 3 (severe) and 4 (death) needs to be reported to the NCA (grades 1 et 2 are notified, traced and analysed at local level of blood establishments). This allows also the harmonization of French data with European and international modalities, for greater comparability of data between countries, particularly EU MS. As a result, the number of SARs in donors reported by France for the 2024 calendar year is significantly lower than that of previous years and cannot be compared given the change in the reporting scope.” Comment EL: “There is a misreporting concerning the grade of severity in the above cases.”

2025 SARE Exercise (2024 data)

SAR in WB Donors by Type of Reaction (Specification)

NEW!

(Percentage Distribution)

Type of Reaction 2023

position # SAR 2024

(+/- 2023)

Vasovagal reaction 1 1 430 (-652)

Nerve injury/irritation 3 220 (-7)

Other 2 120 (-133)

Haematoma (NEW!) - 83

Major cardio-or cerebrovascular event (CCVE) up to 24hours after donation

4 9 (-2)

General - 3 (+3)

Allergic reaction - 0

Citrate reaction - 0

TOTAL - 1 865 (-708)

Note1: significant decrease of vasovagal reactions primarily due to update in FR’s reporting methodology Note2: General - (to be filled out only if data for subcategories are not available) Note3: NEW! Common Approach version 2025, “With regard to the new category of (serious) donor haematoma (added for the 2025 reporting exercise), it should be reserved for donors in whom haematoma was present without (serious) nerve injury/irritation which should be reported under nerve injury/irritation.”

2025 SARE Exercise (2024 data)

SAR in Apheresis Donors by Type of Reaction (Specification)

(Percentage Distribution)

Type of Reaction 2023

position # SAR 2024

(+/- 2023)

Vasovagal reaction 1 214 (-536)

Haematoma (NEW!) - 66

Other 2 43 (-104)

Citrate reaction 3 32 (+2)

Nerve injury/irritation 4 25 (+4)

Major cardio-or cerebrovascular event (CCVE) up to 24hours after donation

5 9 (+3)

Allergic reaction 6 4 (+1)

General - 2 (+2)

TOTAL - 395 (-562)

2025 SARE Exercise (2024 data)

SAR in WB Donors by Type of Reaction and by Country (Percentage Distribution)

NEW!

Note: AT, HR, LV, LT and UK(NI) reported zero SAR

2025 SARE Exercise (2024 data)

SAR in WB Donors by Type of Reaction Absolute numbers; comparative data 2023 - 2024

Country Vasovagal reaction

Absolute Change

2023 2024 Austria (AT) Belgium (BE) 5 18 +13 Bulgaria (BG) 68 77 +9 Croatia (HR) 1 0 -1 Cyprus (CY) 9 8 -1 Czechia (CZ) 7 1 -6 Denmark (DK) 1 6 +5 Estonia (EE) 1 34 +33 Finland (FI) France (FR) 1 022 21 * Germany (DE) 295 333 +38 Greece (EL) 20 14 -6 Iceland (IS) 4 2 -2 Ireland (IE) 6 3 -3 Italy (IT) 161 209 +48 Luxembourg (LU) Netherlands (NL) Norway (NO) 135 135 Poland (PL) 28 26 -2 Portugal (PT) 4 5 +1 Romania (RO) 145 383 +238 Slovakia (SK) 133 126 -7 Slovenia (SI) 23 15 -8 Spain (ES) 0 4 +4 Sweden (SE) 14 10 -4

n 20 20

Other Absolute Change

2023 2024 2 0 -2 0 6 +6

2 1 -1 0 2 +2 2 1 -1

0 1 +1 88 42 * 63 24 -39

1 0 -1 4 2 -2 27 9 -18

24 16 -8 3 0 -3 1 1 0 16 0 -16 13 9 -4

7 6 -1

Nerve injury/irritation

Absolute Change

2023 2024

3 11 +8 87 50 -37

0 2 +2

0 1 +1

26 12 * 77 93 +16 1 1 0

6 5 -1

13 31 +18 4 7 +3

1 0 -1

9 7 -2

Major CCVE up to 24h after donation Absolute

Change 2023 2024

1 0 -1

6 3 * 3 4 +1

1 0 -1

0 1 +1

14 1310 11 4 4

Haematoma

2024

8 32

N/A 14

11 1 2 1 9

NEW!

General Absolute Change

2023 2024

0 3 +3

0 1

*Comment FR: “(…)from the 2nd of January 2024, the reporting of SAR donors focus on the most serious adverse reactions: only grades 3 (severe) and 4 (death) needs to be reported to the NCA (grades 1 et 2 are notified, traced and analysed at local level of blood establishments). This allows also the harmonization of French data with European and international modalities, for greater comparability of data between countries, particularly EU MS. As a result, the number of SARs in donors reported by France for the 2024 calendar year is significantly lower than that of previous years and cannot be compared given the change in the reporting scope.”

Note: in 2023 and 2024, no SAR cases were reported for citrate reactions or allergic reactions

2025 SARE Exercise (2024 data)

SAR in Apheresis Donors by Type of Reaction and by Country (Percentage Distribution)

NEW!

Note: BG, HR, CY, FI, EL, IS, IE, LV, LT, PT, RO and UK(NI) reported zero SAR

2025 SARE Exercise (2024 data)

SAR in Apheresis Donors by Type of Reaction Absolute numbers; comparative data 2023 - 2024

Country Vasovagal reaction

Absolute Change

2023 2024 Austria (AT) 2 3 +1 Belgium (BE) 1 8 +7 Czechia (CZ) 7 5 -2 Denmark (DK) 0 2 +2 France (FR) 631 10 * Germany (DE) 53 77 +24 Iceland (IS) 1 0 -1 Ireland (IE) Italy (IT) 35 66 +31 Luxembourg (LU) Netherlands (NL) Norway (NO) 8 13 +5 Poland (PL) 2 4 +2 Slovakia (SK) 10 24 +14 Slovenia (SI) Spain (ES) 0 1 +1

n 10 11 9 9 3 6

Other Absolute Change

2023 2024 1 1 0 3 +3 0 9 +9 3 2 -1 41 6 * 27 9 -18

1 0 -1 60 2 -58

5 8 +3 2 0 -2 7 3 -4

Nerve injury/irritation

Absolute Change

2023 2024

0 4 +4

0 1 +1 4 1 * 15 15

2 0 -2 0 2 +2

0 2 +2

4 6

Citrate reaction Absolute Change

2023 2024

0 1 +1

6 1 * 4 8 +4

17 14 -3 0 1 +1

3 6 +3

1 0 +1

Haematoma

2024

2 6 12

N/A 33

3 1 9

NEW!

2025 SARE Exercise (2024 data)

SAR in Apheresis Donors by Type of Reaction cont. Absolute numbers; comparative data 2023 - 2024

Country Major CCVE up to

24h after donation Absolute Change

2023 2024

Austria (AT) 2 0 -2 Belgium (BE)

Czechia (CZ)

Denmark (DK)

France (FR) 1 1 * Germany (DE) 3 8 +5 Iceland (IS)

Ireland (IE)

Italy (IT) Luxembourg (LU)

Netherlands (NL)

Norway (NO)

Poland (PL)

Slovakia (SK) Slovenia (SI)

Spain (ES)

Sweden (SE)

n 3 2 2 2

Allergic reaction Absolute Change

2023 2024

0 1 +1

1 0 *

2 3 +1

General Absolute Change

2023 2024

0 2 +2

N/A N/A

0 1

2025 SARE Exercise (2024 data)

Annexes - Executive Summary (2021-2024) - Reporting establishments per capita - Completeness dashboard by metric and country - SAE Additional Information - SAR in Donors Additional Information - SAR (IL 1) (Voluntary)

2025 SARE Exercise (2024 data)

Executive Summary 2021-2024

n = number of countries reporting

Note1: SAE’s increase in 2024 primarily due to RO’s new data Note2: *recipients transfused was obtained with the sum of number of recipients for each type of BC (i.e. WB, RBC, platelets and plasma) from countries which reported per type of BC plus the number of recipients from countries which only reported the overall number (i.e. regardless of type of BC) Note3: *for 2024 the value was obtained with the sum of number of recipients for each type of BC (i.e. WB, RBC, platelets and plasma) from 19 countries (3 219 912) plus the number of recipients from EE and EL (132 307) which only reported the overall number (i.e. regardless of type of BC)

2025 SARE Exercise (2024 data)

Reporting Establishments per capita (per 1 million population (pmp))

population as 1st January Y+1, https://ec.europa.eu/eurostat/

Note: small drop for PT and SK in comparison with 2023 (26 and 13, respectively).

Comment PT: “At the end of 2024, all the institutions that had not performed any type of activity (collection, analysis, processing, distribution, issue or transfusion) of blood or blood components, in the last 3 years, were removed from the database, after being previously questioned.” Comment SK: “Reason for the sudden drop is consolidation of transfusion establishments with blood banks; most transfusion establishments now have their own integrated blood banks. This means that instead of submitting two separate reposrts, they now submitt a single combined annual report.”

2025 SARE Exercise (2024 data)

Completeness Dashboard by metric and country

Note1: HU, MT and LI did not report in 2024. Note2: N/A- data not available; Yes(0)- country reported 0 units.

2025 SARE Exercise (2024 data)

SAE Additional Information

2025 SARE Exercise (2024 data)

SAE classified by Specification Specification SAE Examples/Comments # SAE

Component

defect

60% (2 848 out

of 4 764)

• No additional information provided 2 626

• Platelet units found to have positive bacterial screening after "negative to date" distribution, the units from the donations had already been transfused 88

• PDI that was known at the time of donation but not mentioned by the donor OR information that led to the donor's refusal but may have influenced the quality of former donations (e.g.

newly diagnosed malignant disease or Borellia infection) 58

• Non available information (N/A) 15

• Repeat donor tested positive for HCV 14

• Insufficient deferral period after risk of infection due to incorrect programming in EDP 3

Human error

14% (675 out of

4 764)

• Non available information (N/A) 129

• No additional information provided 101

• Wrong patient transfused: resulting from a combination of multiple successive failures during the same BC prescription process. The failures are combined from the error of identity of

patient in prescribing BCs, failures of communication between the staff taking care of the patient and the staff issued BCs, the error in checking of identity patient in issuing of these

BCs in the BE or in the HBB, the error in checking of identity patient in the clinical area (at the reception of BCs and/or at bedside). 10% occurred in urgent settings, none occurred

during night shifts (8 PM to 8 AM); 16% occurred during week-end or public holidays. When a SAR ABO incompatibility results from a 'wrong patient transfused', they are not included in

this category. They are reported only as SAR ABO incompatibility.

• Most reported SAEs were related to unreported recent travel to malaria- or Chagas-endemic areas, largely due to donor omission and insufficient emphasis during the pre-donation

interview, although no TTIs occurred and all post-donation testing was negative. Less frequently, procedural omissions (such as missed Hb testing or shortened inter-donation

intervals) were reported, none of which resulted in adverse consequences, and all events were followed by systematic reminders of existing procedures.

• Donor accepted despite info for exclusion; insufficient donor deferral 26

• Delayed transfusion (DT): resulting from a combination of multiple successive failures during the same BC prescription process. The failures are combined from the delay in

prescribing BCs, failures of communication between the staff taking care of the patient and the staff issuing BCs, the delay in issuing these BCs, the delay in their transport/shipment

from the BE or from the HBB to the transfusion healthcare area and the delay in the transfusion procedure. This DTs occur mainly in urgent settings (20%) and in in non-urgent settings

(medical and intensive care units 12%, emergency department 13% and obstetrics 4%. And among DTs in urgent settings, 3% occurred during night shifts (8 PM to 8 AM).

• Lack of concentration 20

• Overcollection due to plasma bag not hanging freely (2), doctor mistakenly prescribed too large collection volume(5), overcollection due to incorrect setting on device (6) 13

• Transfusion/Issue of incorrectly labelled component 11

• Failure of the PDI system: they are due to non-application of procedures. A systematic reminder is carried out for staff who have not respected these procedures 10

• Transfusion on an invalid sample 10

• ICBT e.g. due to insufficient or no bedside check 9

• ICBT due to incorrect product allocation during issue 9

• WBIT, labelling error, donor mix-up 8

• Error in blood component transportation 8

• Wrongful registration of the blood donor 5

• Incorrect blood component issued by blood bank 5

• Incorrect labelling after irradiation, Errors during irradiation, omission of quality control 4

• FFP units which were not transfused to patients returned to HBB by clinic without marked as unsuitable. HBB realized that the specific FFP units were not suitable for transfusion and

after preventive and corrective actions the units were discarded. 3

• Microbe contamination in platelet product (which were not transfused), possibly due to venipuncture step 3

• The donor had too poor language skills. They did not adequately understand what they signed on 3

2025 SARE Exercise (2024 data)

SAE classified by Specification Specification SAE Examples/Comments # SAE

Equipment

failure

11% (510 out of

4 764)

• No additional information provided 423

• These rare SAEs are subject to systematic equipment maintenance check and systematic reminders of the procedures and the need to respect them 38

• Non available information (N/A) 12

• Burst blood bag 11

• Missing or invalid positive controls for infection serology 3

• Incorrect weight indication on the weigher/mixer resulting in too much blood volume being taken 2

• IT-software error and machine malfunction 2

• Inadequate blood typing reagents 2

• Weld failure 2

• Incorrect weak D declaration as D negative due to EDP misprogramming 1

• Omission of alloantibody screening test of donors due to EDP misprogramming 1

• Overfilling of EC, probably due to defective scale 1

• The machine drew to much plasma 1

Other

7% (367 out of 4

764)

• No additional information provided 83

• Positivity ALT during testing 70

• The donor did not provide correct or full information at the donation 50

• Collapse during whole blood collection 40

• Covid, Herpes Zoster in donor selection 24

• Rupture veins during whole blood collection 17

• Positivity NCT during testing 11

• The interview form used is inadequate 9

• Positive viral- or microbiological tests came back after donation 8

• The transfused component doesn`t meet the requirements (incorrect blood antigen determined) 7

• Leaking pack noted on arrival to hospital x 3, Clots observed in unit x 1, Minor red cell sediment in ports, not significant to transfusion and no patient impact x 1, Leak noted in unit pre-

transfusion x 1, Unit haemolysed x 1 7

• Positivity anti HCV during testing 4

• Patient hid the information about the therapy he receives/his diagnosis. Blood components were distributed for use 3

• Extensive floods 3

• National epidemiological situation changed (increased amount of HEV cases due to sausages); additional blood donation testing was started, and positive cases were found on archive

samples; the blood products were already transfused 2

2025 SARE Exercise (2024 data)

SAE classified by Specification Specification SAE Examples/Comments # SAE

System failure

5% (229 out of 4 764)

• Failure of the IT systems/ Transport: these rare SAEs are subject to systematic equipment maintenance check and systematic reminders of the procedures and the need to respect them 36

• Non available information (N/A) 34

• Donor eligibility violations 33

• Delayed transfusion: resulting from a combination of multiple successive failures during the same BC prescription process (…) 15

• Wrong patient transfused: resulting from a combination of multiple successive failures during the same BC prescription process (…) 14

• Little knowledge about rules and procedures 12

• No additional information provided 9

• Lack of routines/internal procedure 3

• Stress 3

• Typing errors when entering positive infection parameters were interpreted as negative by EDP due to poor programming 2

• BCs issued without specific characteristics - irradiation and/or CMV 2

• Errors due to delayed process validation 1

• Different procedure for accepting donor regarding medical declaration form 1

• Failure to provide irradiated units after introduction of new lab-system 1

• Issue of donor-incompatible plasma for patient with planned kidney transplant 1

Materials

3% (135 out of 4 764)

• Burst blood bag 49

• Burst blood bag, plasma chylostasis 33

• Plasma chylostasis 30

• Faulty pipette tips or faulty positive controls led to invalid test results 2

• Non available information (N/A) 1

• No additional information provided 1

• Faulty lot number of serological immunoassay cards 1

• The units were pathogenically reduced but the exposure report had an incorrect date due to a date change in the system 1

• Wrong result of the phenotype resulting from a default reagent 1

• False positive results due to faulty reagent lot number 1

2025 SARE Exercise (2024 data)

SAR in Donors Additional Information

2025 SARE Exercise (2024 data)

SAR in Donors – Additional information provided

Country (# SAR)

WB vs Apheresis Donation

Comments (related to ‘Other’ and Major CCVE)

Belgium (56)

71% (40) WB 29% (16) Apheresis

• WB ‘Other category’: 4 thrombophlebitis; 1 tendon-muscle injury; 1 erysipelas

• Apheresis ‘Other’ category: 3 thrombophlebitis

Cyprus (11)

100% WB ‘Other’ category: after removing the needle from the donor's arm, the blood flow could not stop, and he was transferred to the Emergency Room of the hospital and later released.

Czechia (18)

17% (3) WB 83% (15) Apheresis

• WB ‘Other category’: 2 vasovagal reaction with fall and laceration

• Apheresis ‘Other’ category: 3 spasm and hypotension due to replacement of physiological saline and citrate; 1 tissue infection (Str. pyogenes); 2 vasovagal reaction with spasm; 3 vasovagal reaction with fall and laceration

Finland (1)

100% WB ‘Other’ category: 28 hours after whole blood donation, donor experienced chest pain during strenuous labour, which resulted in hospitalisation, myocardial infarction and operation (balloon angioplasty with stent) and diagnosing of coronary artery disease. The donor had been without cardiac symptoms before the event and had been in follow-up due to high cholesterol levels. Blood donation and the resulting dehydration and lowered haemoglobin may have been contributing factors leading to the cardiovascular event. The donor's coronary artery disease had probably been developing for a long time but was asymptomatic and undiagnosed.

Seriousness: Serious; Severity: Grade 3 (classified using the AABB Severity Grading Tool of Blood Donor Adverse Events: category E; acute cardiac symptoms; myocardial infarction --> diagnosis medically confirmed); Imputability: 1/possible

Germany (615)

79% (486) WB

21% (129) Apheresis

• WB ‘Other category’: 9 thrombophlebitis; 1 inflammatory tissue reaction; 1 phlegmon; 7 venous thrombosis; 1 pseudoaneurysm; 1 allergic reaction; 1 unclear neurological symptoms; 1 cerebral seizure; 1 anaemia; 1 traffic accident after donation

• Apheresis ‘Other’ category: 2 thrombophlebitis; 1 phlegmon; 1 cyst formation in the crook of the elbow; 3 haemolysis; 1 unclear neurological symptoms; 1 status epilepticus

Italy (350)

66% (232) WB 34% (118) Apheresis

• WB ‘Other category’: 5 post-donation accident-related head trauma and 4 thrombophlebitis

• Apheresis ‘Other’ category: 2 thrombophlebitis

Luxembourg (2)

50% (1) WB 50% (1) Apheresis

• A donor presented for WB donation, filled in the pre-donation questionnaire and got a medical consultation before the donation. No contraindication for a blood donation was detected (normal physiological parameters, negative answer on exceptional bleedings). A bag of WB had been collected without any problems. By performing the hemogram, the laboratory technician found on the same day a haemoglobin result of 6.5 g/l. He was immediately informed by the BTC about the result and said that he was in a good shape and had not detected any fatigue. During the phone call, he said that he has slight bleeding due to haemorrhoids since approximately 1 year. He was informed to contact as soon as possible his treating medical doctor. He did a consultation at an emergency department, got two blood transfusions of RBC. Unfortunately, we are unaware of the etiology.

2025 SARE Exercise (2024 data)

SAR in Donors – Additional information provided

Country (# SAR)

WB vs Apheresis Donation

Comments (related to ‘Other’ and Major CCVE)

Netherlands (5)

no distinction can be made based on donation type

‘Other’ category: 4 vasovagal reactions and 1 venipuncture related/thrombophlebitis

Norway (223)

87% (193) WB 13% (30) Apheresis

• WB ‘Other category’: 1 local allergic reaction; 6 other systemic reactions, 9 reactions with local pain in the arm not judged to be due to nerve irritation • Apheresis ‘Other’ category: 6 local pain reactions not judged to be due to nerve irritation; 2 systemic reactions

Portugal (8)

100% WB ‘Other’ category: 1 brachial artery pseudoaneurysm

Slovenia (18)

89% (16) WB 11% (2) Apheresis

WB: 1 Major CCVE up to 24 hours after donation: The donor suffered an acute myocardial infarction in the evening around 11 pm. The imputability assessment: probably, likely

Sweden (23) (2 cases from 2023)

(23) WB N/A Apheresis

WB ‘Other category’: 3 artery puncture; 3 skin reaction and received antibiotics

2025 SARE Exercise (2024 data)

SAR in Donors – Additional information provided

Country (# SAR)

SAR Rate (calculated by

country)

SAR by Gender

Type of Donor WB vs Apheresis

Donation Comments

France (111)

4.2 SARs per 100 000 donations (2 650 837 donations) or 0.7 SARs per 10 000 blood donors (1 557 675 donors)

75% in women vs 25% in men

85% regular blood donors vs 15% first- time blood donors (regardless of inclusion criteria)

77% (86) WB 23% (25) Apheresis

45% occurred in fixed site of BE vs 55% in mobile collection site

• WB Major CCVE event (3 SAR): 2 superficial vein thrombosis, 1 deep vein thrombosis. All occurred in current women donors

• WB ‘Other category’: 18 iron deficiencies, 16 anaemia, 2 arterial punctures, 2 tendon injuries, 1 arteriovenous fistula, 1 local infection, 1 lymphangitis and 1 uncategorised complication of donation (atypical chest pain)

• Apheresis Major CCVE (1 SAR): 1 superficial vein thrombosis, occurred in a current male donor • Apheresis ‘Other category’: 3 lymphangitis, 1 anaemia, 1 iron deficiency, 1 tendon injury

Ireland (10) (2 from 2022, 2 from 2023 and 6 from 2024)

133 996 attempted WB donations and 8 339 attempted apheresis donations in the calendar year 2024 (total of 142 335 attempted donations).

The rate of SARs for WB and apheresis donations was therefore 1 in 14 234 attempted donations.

5 donors are female and 5 are male

100% WB • 3 SARs classified as vasovagal reactions, 1 was an immediate vasovagal reaction without injury, 2 were delayed vasovagal reactions with injury. ➢ The immediate vasovagal reaction occurred in a 46-year-old male donor with a history of 8

previous donations. He briefly lost consciousness for about 2 minutes. During this period, he appeared to stop breathing and had no detectable pulse, prompting clinic staff to start CPR and use a portable AED. The AED detected electrical activity (no shock advised), and the donor quickly regained consciousness. He was transported to hospital where tests confirmed there was no cardiac arrest. The donor recovered completely, was discharged the next morning, and advised to follow up with his GP. He is now permanently excluded from donating blood.

➢ The two donors who had delayed vasovagal reactions were regular female donors; one was 51 years of age and was unconscious for > 60 seconds without seizure-like activity or incontinence; the second donor was 61 years of age and was unconscious for < 60 seconds and did not have seizure-like activity or incontinence. Both donors were admitted to hospital for overnight observations. The 51-year-old donor received 3 litres of intravenous fluid due to hypotension. Both donors made a full recovery and are permanently excluded from donating.

• 5 SARs classified as nerve injury/nerve irritation, 4 of these were nerve injuries on needle insertion and 1 was a nerve irritation. Symptoms lasted longer than 12 months in all 5 cases.

• ‘Other’ category: 2 cases of painful arms, in both donors, symptoms persisted for more than 12 months after donation.

2025 SARE Exercise (2024 data)

SAR (IL 1) (Voluntary)

2025 SARE Exercise (2024 data)

Absolute numbers; comparative data 2023 - 2024

Total SAR (IL 1) and Fatalities (IL 1) by Type of BC

Total Number of SAR (IL 1)

2023 2024 %

Change

RBC 1 190 1 092 -8

Platelets 252 194 -23

Plasma 161 100 -38

MTOC 77 71 -8

WB 0 0 -

TOTAL 1 680 1 457 -13

n (RBC) 20 19

n (Platelets) 17 13

n (Plasma) 11 11

n (MTOC) 7 9

n (WB) 0 0

Total Number of Fatalities (IL 1)

2023 2024 Absolute Change

RBC 16 14 -2

Platelets 5 3 -2

Plasma 0 1 +1

MTOC 1 3 +2

WB 0 0 -

TOTAL 22 21 -1

n (RBC) 4 5

n (Platelets) 2 3

n (Plasma) 0 1

n (MTOC) 1 3

n (WB) 0 0

2025 SARE Exercise (2024 data)

Absolute numbers; comparative data 2023 - 2024

Total SAR (IL 1) by Type of Reaction

2025 SARE Exercise (2024 data)

Total SAR (IL 1) - TTI

n (TTBI) 1 2

n (TTVI) 2 1

n (TTPI) 1 0

Type of TTI 2023 2024 Absolute Change

TTBI 15 12 -3

TTVI 5 1 -4

TTPI 1 0 -1

TOTAL 21 13 -8

Absolute numbers; comparative data 2023 - 2024 Absolute numbers; by type of BC

Note1: zero TTFI and TTPRI cases reported in both 2023 and 2024. Note2: zero TTIs reported in plasma or WB in both 2023 and 2024. Note3: TTBI- RBC- Serratia marcescens et Proteus mirabilis (1), Yersinia enterocolitica (1), Bacillus cereus (1), Streptococcus mitis and Streptococcus oralis (1), Klebsiella oxytoca, E. coli and Staphylococcus haemolyticus (3); Platelets- Staphylococcus warneri (1), Staphylococcus hominis and Staphylococcus epidermidis (1), Bacillus cereus (1), Streptococcus dysgalactiae (1) ; MTOC- Staphylococcus aureus (1)

TTVI- RBC- HEV (1)

2025 SARE Exercise (2024 data)

Total Fatalities (IL 1) by Type of Reaction, Type of BC and Country Absolute numbers

Country (#) RBC Platelets Plasma MTOC

Belgium (3) 2 1

Finland (2) 1 1

France (2) 2

Germany (8) 7 1

Netherlands (3) 2 1

Poland (2) 1 1

Portugal (1) 1

Fatalities (IL 1) = 21

7 Countries Reporting: BE, FI, FR, DE, NL, PL, PT

RBC

TTBI

A 64-year-old patient with HIV/AIDS in a severely reduced and highly unstable general condition, septic after transfemoral amputation, and additionally pneumogenic sepsis developed after transfusing of 2 ECs pulmonary oedema and an increase in catecholamine requirement (already previously 4mg arterenol/hour). Development of lactic acidosis and progressive drop in blood pressure until resuscitation was necessary. Resuscitation ultimately unsuccessful - exitus lethalis. An EC showed rapidly growing Yersinia enterocolitica. A contamination of the EC due to reflux of the patient's blood was discussed, however, a possible causality cannot be ruled out here due to the temporal relationship of the transfusion and the deterioration.

Platelets A 63-year-old patient with newly diagnosed B-cell lymphoma received two pool TCs preoperatively before port placement due to thrombocytopenia. About an hour later, dyspnoea, a rise in temperature and septic shock occurred. Bacillus cereus was found in the blood cultures, as well as in one of the pool TCs. The patient died the next day as a result of the sepsis despite antibiotic treatment. A comparative antibiotic resistance test or sequencing of the bacterial DNA was not carried out.

Type of Reaction 2023 2024 Absolute change

TACO 7 8 +1

Anaphylaxis/ hypersensitivity

3 4 +1

Other 2 2 0

TTBI 2 2 0

Immunological haemolysis due to other alloantibody

4 1 -3

TRALI 1 1 0

Hypotensive transfusion reaction

0 1 +1

TAD 0 1 +1

Non-immunological haemolysis

3 1 -2

2025 SARE Exercise (2024 data)

Next step

• 2025 SARE exercise (data 2024) FINAL REPORT

[email protected]

Thank you for your attention

SARE Blood 2025 (data 2024) Annual Summary Report.pdf

EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Unit D2 – Medical Products: quality, safety, innovation

(Data collected from 01/01/2024 to 31/12/2024 and

submitted to the European Commission in 2025)

HAEMOVIGILANCE

ANNUAL SARE REPORT 2025

Haemovigilance Annual Report 2025 2

Contents

INTRODUCTION ............................................................................................................................................. 3 EXECUTIVE SUMMARY ................................................................................................................................. 4 METHODOLOGY ............................................................................................................................................ 5

Data collection and analysis .......................................................................................................... 5

Data reporting completeness ........................................................................................................ 6

Denominator data ........................................................................................................................... 6

Limitations ...................................................................................................................................... 6

Key indicators definitions .............................................................................................................. 6

Updates and improvements........................................................................................................... 8

RESULTS ........................................................................................................................................................ 9

1 Activity Dataset .................................................................................................................10

1.1 Yearly trends (2021–2024) ...................................................................................................10

1.2. Geographic distribution .........................................................................................................14

1.3. Overview of volume of activity by type of BC .......................................................................19

1.4. Country-specific trends (2023 vs. 2024) by type of BC .......................................................20

2 Serious Adverse Reactions in Recipients (Mandatory) ......................................................22

2.1 Yearly trends (2021–2024) ...................................................................................................23

2.2 Geographic distribution .........................................................................................................24

2.3 Yearly trends (2021–2024) by type of BC ............................................................................25

2.4 Country-specific trends (2023 vs. 2024) by type of BC .......................................................26

2.5 Overview of SAR (IL 2-3) and fatalities (IL 2-3) by type of BC .............................................27

2.6 Yearly trends (2021–2024) by type of reaction ...................................................................29

2.7 Overview of SAR (IL 2-3) and fatalities (IL 2-3) by type of reaction ....................................31

2.8 Fatalities (IL 2-3) in recipients – case studies .....................................................................36

3 Serious Adverse Events (Mandatory) ................................................................................39

3.1 Yearly trends (2021–2024) ...................................................................................................40

3.2 Geographic distribution .........................................................................................................41

3.3 Country-specific trends (2023 vs. 2024) ..............................................................................42

3.4 Overview of SAE by activity step ...........................................................................................43

3.5 Yearly trends by specification (2021–2024) ........................................................................47

3.6 Overview of SAE by specification .........................................................................................49

4 Severe Adverse Reactions in Donors (Voluntary) ..............................................................56

4.1 Geographic distribution .........................................................................................................56

4.2 Country-specific trends (2023 vs. 2024) ..............................................................................58

4.3 Overview of SAR in donors by type of reaction ....................................................................60

4.4 Fatalities in donors ................................................................................................................65

CONCLUSIONS ............................................................................................................................................ 66 List of Abbreviations ................................................................................................................................... 69 List of Figures .............................................................................................................................................. 70 List of Tables ............................................................................................................................................... 71 List of Annexes ............................................................................................................................................ 71

Haemovigilance Annual Report 2025 3

INTRODUCTION

Blood transfusion is a vital medical procedure that supports a wide range of healthcare specialties,

saving millions of lives across Europe each year. However, as with any substance of human origin,

transfusions carry inherent risks, including disease transmission, immune incompatibilities and

other potential adverse reactions. To ensure patient and donor safety, the European Union (EU) has

established a comprehensive framework of safety and quality measures under EU Blood

Legislation1. Despite these safeguards, adverse reactions and events can still occur, making the role

of haemovigilance in transfusion medicine essential.

Haemovigilance encompasses a series of surveillance procedures that monitor the entire

transfusion process, from blood donation and processing to transfusion and patient follow-up.

According to the World Health Organization (WHO), haemovigilance aims to continuously improve

the quality of the transfusion chain through corrective and preventive measures, ultimately

enhancing donor and patient safety and reducing wastage.

Through national haemovigilance systems, EU Member States (MS) are required to report Serious

Adverse Reactions (SAR) and Serious Adverse Events (SAE) annually to the European Commission

(EC), in line with legislative obligations. SAR refer to transfusion-related incidents that result in actual

harm to donors or recipients, whereas SAE involve incidents that could compromise the quality or

safety of blood components but do not necessarily cause harm.

Since 2012, voluntary reporting of donor-related SAR has been included in the EU's haemovigilance

framework, further strengthening the commitment to comprehensive transfusion safety monitoring.

The 2025 Haemovigilance Report provides an in-depth analysis of SARE (Serious Adverse Reactions

and Events) data for the year 2024 submitted to the EC by 28 European countries, highlighting key

findings, trends and challenges faced in ensuring safe and effective blood transfusions in Europe.

1 Article 8 of Directive 2005/61/EC provides that MS shall submit to the EC an annual report, by 30 June of the following year, on the notification of SARE received by the NCA using the formats in Part D of Annex II and Part C of Annex III.

Haemovigilance Annual Report 2025 4

EXECUTIVE SUMMARY

Haemovigilance Annual Report 2025 5

METHODOLOGY

Data collection and analysis This report provides a summary of the national data submitted to the EC by all EU MS (except

Hungary and Malta) and three non-EU countries (Iceland, Norway and UK (Northern Ireland))

pertaining to the reporting period from 1 January to 31 December 2024.

As in previous years, the EC provided national competent authorities (NCA) with the following tools

to facilitate a standardised online data reporting approach:

1) An electronic reporting form (version 2025)

2) The Common Approach, version 2025 [1],which complements the electronic reporting form

and provides updated user instructions for data compilation.

The sequence of steps comprised (and involved parties) from data collection to the publication of

the final report are shown below.

Summary of the annual reporting of SARE for blood and blood components: https://health.ec.europa.eu/blood-tissues-cells-and-

organs/key-documents_en

The preliminary results of the EDQM’s SARE analysis (data 2024) were verified by the reporting

countries and also presented at the annual meeting of the Vigilance and Traceability Working Group

(previously known as VES, the Vigilance Expert Subgroup) of the SoHO Coordination Board during

the 27–28th April 2026.

Haemovigilance Annual Report 2025 6

Data reporting completeness The annual data on SARE for blood and blood components were reported by 25 EU MS and three

non-EU countries that submitted their national data on a voluntary basis, comprising aggregated

data from 3 190 reporting establishments. Refer to Annex 2. Reporting establishments per capita

(pmp) for their geographical distribution in Europe.

Regarding the percentage of reports received, 21 reporting countries confirmed receipt of 100% of

reports, four countries received 80-99% of the expected data and two countries’ 50-80%. One country

was not able to provide any information. For more details, refer to Annex 3. Completeness

dashboard per metric per country.

Denominator data • The total number of units of blood/blood components (BC) transfused (i.e. the sum of whole

blood (WB), red blood cells (RBC), platelets and plasma units) annually was used as the

denominator to calculate SAR (IL 2-3) incidence per 100 000 units transfused.

• 82% (23 of 28) countries reported this denominator.

• The total number of units blood/BC processed annually was used as the denominator to

calculate SAE incidence per 100 000 units processed.

• 100% (28 of 28) countries reported this denominator.

• The total number of WB collections was used as the denominator to calculate SAR incidence

in WB donors per 100 000 donations.

• 93% (26 of 28) countries provided this denominator.

• The total number of apheresis collections was used as the denominator to calculate SAR

incidence in apheresis donors per 100 000 donations.

• 89% (25 of 28) countries provided this denominator.

Annex 3. Completeness dashboard per metric per country outlines whether each reporting country

have denominator data valid for rate calculations.

Limitations • Data variability: incomplete reporting and inherent variations in reporting accuracy and

quality must be considered during the interpretation of the results of SARE analysis.

• Data coverage: variations in the number of reporting countries year-over-year may influence

total counts and calculated metrics. Whenever possible, data were normalised to account

for these differences and, for transparency, the number of countries reporting each year is

included alongside key metrics.

Key indicators definitions • Transfusion rate per country in data year Y is an indicator that reflects how frequently

blood/BC are administered within a population, providing insight into national clinical

practice patterns and overall demand for blood/BC. It is the total number of units of blood/BC

transfused as a function of the size of the reference population and expressed per one

thousand population.

o How it is calculated: total number of units of blood/BC transfused x (1/population

size) x 1 000.

Haemovigilance Annual Report 2025 7

o The same logic is used for determining the issuance, processing, donation and

recipient rates per country in data year Y.

• Median per-country transfusion rate in data year Y represents the typical level of transfusion

activity across reporting countries, expressed as the middle value of national transfusion

rates for that data year.

o How it is calculated: the transfusion rate (per 1 000 population) is calculated for each

reporting country of said data year Y and then the median is taken.

o The median is independent of the number of reporting countries and fairly robust

against extreme values (e.g., countries with abnormally high or low transfusion

rates).

o The same logic is used for determining the median per-country issuance, processing,

donation and recipient rates in data year Y.

• RBC transfusion rate per country in data year Y isthe number of units of RBC transfused as

a function of the size of the reference population and expressed per one million population

(pmp).

o How it is calculated: number of units of RBC transfused x (1/population size) x 106.

o The same logic is used for determining the WB, platelets and plasma transfusion

rates per country in data year Y.

• Median per-country RBC Transfusion rate in data year Y represents the typical level of

transfusion activity of RBC across reporting countries, expressed as the middle value of

national RBC transfusion rates for that data year.

o How it is calculated: the RBC transfusion rate (pmp) is calculated for each reporting

country of said data year Y and then the median is taken.

o The same logic is used for determining the median per-country WB, platelets and

plasma transfusion rates per country in data year Y.

• Total SAR incidence in data year Y is an indicator of the overall burden of SAR within the

transfusion system across Europe of said data year Y, reflecting its general safety

performance; expressed per 100 000 units of blood/BC transfused; best for international

comparisons.

o How it is calculated: total number of SAR cases reported divided by the total number

of units of blood/BC transfused × 100 000.

o The numerator (total number of reported SAR) and the denominator (total number of

units of blood/BC transfused) includes different sets of countries. Specifically, some

countries report the number of SAR cases but do not provide the corresponding

denominator, or some countries report the number of units transfused but report zero

SAR. As a result, the total pooled incidence rate may not represent a strictly matched

country set and should be interpreted alongside median per-country rates and

denominator completeness table to properly assess trends and comparability across

the EU.

o The same logic is used for determining the total fatalities (IL 2-3) incidence

(expressed per 100 000 units of blood/BC transfused), total SAE incidence

(expressed per 100 000 units of blood/BC processed) and total SAR incidence in WB

or apheresis donors (expressed per 100 000 WB or apheresis collections,

respectively).

• Median per-country SAR incidence in data year Y is an indicator of the “typical” SAR rate

across reporting countries of said data year Y, serving as a benchmark for comparing

transfusion safety performance and identifying which countries have higher or lower

incidence than this central value; expressed per 100 000 units of blood/BC transfused.

Haemovigilance Annual Report 2025 8

o How it is calculated: the SAR rate is calculated for each reporting country (only those

countries where both SAR and units of blood/BC transfused are available) and then

the median is taken.

o The median is independent of the number of reporting countries and fairly robust

against extreme values (e.g., countries with abnormally high or low SAR incidence).

o The same logic is used for determining the median per-country SAE incidence in data

year Y (expressed per 100 000 units of blood/BC processed) and the median per-

country SAR incidence in WB or apheresis donors (expressed per 100 000 WB or

apheresis collections, respectively).

Updates and improvements The 2025 edition of the SARE report incorporates some structural and methodological updates

aimed at improving transparency, comparability, regulatory clarity and the analytical utility of the

reported data:

• A critical update is the structural separation of SAR in recipients by imputability level. The data

analyses now explicitly isolate "in-scope" SAR (IL 2-3), which are legally mandated under EU

reporting directives, from "voluntary" SAR (IL 1) (see Annex 7). This structure empowers NCA

and external reviewers to filter, compare and aggregate statutory metrics with high precision

and confidence.

• A completeness dashboard per metric per country has been introduced (see Annex 3). This

provides immediate visibility into the integrity of the denominator data, clearly highlighting

where data gaps may compromise incidence analysis. Additionally, the methodology chapter

has been complemented through a new, dedicated key indicators definitions section that

explicitly details how median and total incidence rates are calculated.

• Another major update is the qualitative thematic analysis of the free-text narrative data

(comments) submitted alongside SAE reports, covering all specification categories. This

approach is essential in order to highlight failure modes, systemic vulnerabilities and reporting

quality gaps.

• For major chapters, the introduction text has been extended, particularly for SAE. This

expansion aims to reduce interpretative ambiguity and data variability that stems from

inconsistent national reporting practices.

• A “key countries shaping the landscape” box, including brief national notes from countries,

when available, across different metrics, clarifying whether differences reflect system

maturity, system maturity, national clinical practice patterns, or recent changes in reporting

methodology.

Haemovigilance Annual Report 2025 9

RESULTS

The outcomes of the data analysis are quantitative and qualitative indicators intended to provide

information necessary for interpretation and conclusions regarding the safety of transfusion within

the European space.

The SARE results are presented in four sections, each including the overall results and, where

feasible, separate results for each type of BC (i.e. WB, RBC, platelets, plasma and more than one BC

(MTOC2)):

1. Activity dataset

a. Yearly trends in donation (WB and apheresis), issuance, transfusion, processing and

recipient rates (2021–2024)

b. Geographic distribution of donation, issuance, transfusion and recipient rates

c. Overview of volume of activity by type of BC; comparative analysis with 2023

d. Country-specific trends (2023 vs. 2024) in transfusion rates by type of BC

2. SAR (IL 2-3) in recipients

a. Yearly trends in SAR (IL 2-3) incidence (2021–2024)

b. Geographic distribution of SAR (IL 2-3) incidence

c. Yearly trends in median per-country SAR (IL 2-3) incidence by type of BC (2021–2024)

d. Country-specific trends (2023 vs. 2024) in SAR (IL 2-3) incidence by type of BC

e. Overview of SAR (IL 2-3) and fatalities (IL 2-3) by type of BC; comparative analysis

with 2023

f. Yearly trends in SAR (IL 2-3) and fatalities (IL 2-3) by type of reaction (2021–2024)

g. Overview of SAR (IL 2-3) and fatalities (IL 2-3) by type of reaction; comparative

analysis with 2023

h. Fatalities (IL 2-3) in recipients – case studies

3. SAE

a. Yearly trends in SAE incidence (2021–2024)

b. Geographic distribution of SAE incidence

c. Country-specific trends (2023 vs. 2024) in SAE incidence

d. Overview of SAE by activity step

e. Yearly trends in SAE by specification (2021–2024)

f. Overview of SAE by specification (including Qualitative Thematic Analysis)

4. SAR in donors

a. Geographic distribution of SAR incidence in WB and apheresis donors

b. Country-specific trends (2023 vs. 2024) in SAR incidence in WB and apheresis donors

c. Overview of SAR by type of reaction in WB and apheresis donors; comparative

analysis with 2023

d. Fatalities in donors

Note 1: wherever N/A is mentioned throughout the text it means data not available.

Note 2: key raw data for each MS for the period 2021–2024 are listed in the Annexes 8–13.

More Than One Component (MTOC) reflects exposure to multiple component categories over the reporting period, irrespective of timing or clinical

episode.

Haemovigilance Annual Report 2025 10

1 Activity Dataset

1.1 Yearly trends (2021–2024)

1.1.1. Donation (Whole Blood and Apheresis) rates

Considering the demographic data3 of the reporting countries, Figure 1 presents the median of

country-specific WB donation/collection rate (per 1 000 population) across all reporting countries

from 2021 to 2024.

Between 2021 and 2023, the median WB donation rate remained stable at approximately 34

donations per 1 000 population. In 2024, however, a marked decrease to 31.8 was observed (an 8%

drop compared with 2023).

Figure 1. Yearly trendinwhole blood donation rate (median per-country) per 1 000 population; 2021–2024

Figure 2 presents the median of country-specific apheresis donation rate (per 1 000 population)

among reporting countries from 2021 to 2024.

The median per-country apheresis donation rate remained broadly stable between 2021 and 2024,

fluctuating within a narrow range.

3 https://ec.europa.eu/eurostat/ (Population on 1January Y+1 – total)

Key findings ➢ WB donation rate (median) declined 8% (31.8 vs 34.4 in 2023) while the apheresis’ remained stable (2.5 vs 2.6).

➢ RBC, platelets and plasma transfusion rates (median) decreased slightly across all BC types except WB.

➢ Plasma issuance volume increased by 13% in comparison with 2023.

➢ Recipient numbers increased across all BC types.

Haemovigilance Annual Report 2025 11

Figure 2. Yearly trend in apheresis donation rate (median per-country) per 1 000 population; 2021–2024

1.1.2. Blood/BC issuance, transfusion and processing rates

Figure 3 shows the median of country-specific blood/BC issuance, transfusion and processing rates

(per 1 000 population) across all reporting countries from 2021 to 2024.

Figure 3. Yearly trends in blood/BC issuance, processing and transfusion rates (median per-country) per 1

000 population; 2021–2024

The downward trend in issuance rates from 2021 to 2024 is paralleled by overall stable transfusion

rates, suggesting that the reduction in issued units is primarily driven by improved inventory

management and wastage reduction practices rather than a decline in clinical demand. Between

2021 and 2024, the median processing rate showed an overall upward trajectory.

Haemovigilance Annual Report 2025 12

1.1.3. Transfusion rates per type of BC

Figure 4 shows the median of country-specific RBC transfusion rate (per one million population,

pmp) across all reporting countries from 2021 to 2024. There has been a continuous decline in RBC

transfusion rate from 2022 onwards.

Figure 4. Yearly trend in RBC transfusion rate (median per-country) pmp; 2021–2024

Figure 5 presents the median of country-specific platelets and plasma transfusion rates (pmp)

across all reporting countries from 2021 to 2024.

Figure 5. Yearly trends in platelet and plasma transfusion rates (median per-country) pmp; 2021–2024

Note: for plasma, n includes countries that reported zero units and consequently a transfusion rate of zero.

Between 2021 and 2024, the median platelet transfusion rate remained relatively stable, fluctuating

within a narrow range, with a modest peak at 4 778 in 2023. In contrast, the median plasma

transfusion rate shows more marked fluctuations. After increasing initially from 3 872 in 2021 to 4

243 in 2022, it declined significantly in 2023, stabilising at lower level in 2024.

Haemovigilance Annual Report 2025 13

Figure 6 displays the median of country-specific WB transfusion rate (pmp) across reporting

countries from 2021 to 2024. From 2021 to 2023, the trend was fairly stable with a pronounced

increase in 2024.

Figure 6. Yearly trend inWB transfusion rate (median per-country) pmp; 2021–2024

Note: n includes countries that reported zero units and consequently a zero rate.

1.1.4. Summary by type of BC (2023 vs. 2024)

As shown in Table 1, in comparison with 2023, the transfusion rates (median) decreased slightly

across all types of BC except for WB.

Table 1. Summary of transfusion rates (median per-country) pmp by type of BC; 2023 vs. 2024

1.1.5. Recipient rate

Figure 7 displays the median of country-specific recipient (regardless of type of BC) rates (per 1 000

population) among reporting countries from 2021 to 2024. In general, recipient data has been

plateauing from 2021 until 2023, with a marginal decrease in 2024.

Haemovigilance Annual Report 2025 14

Figure 7. Yearly trend in recipient rate regardless of type of BC (median per-country) per 1 000 population;

2021–2024

1.2. Geographic distribution

1.2.1. Donation (Whole Blood and Apheresis) rates

Twenty-six countries (AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, EL, IS, IE, IT, LV, LU, NL, NO, PL, PT,

RO, SI, ES, SE and UK(NI)) reported a total of 15 679 193 WB collections in 2024. This was a minor

decrease over the previous year, when 16 068 007 collections were also reported by 26 countries.

In terms of apheresis collections, 25 countries (all the above minus SE) reported a total of 7 590 344

collections, representing a 4% increase compared to the 7 286 075 collections in 2023.

Considering the demographic data4 of the reporting countries in 2024, the WB and apheresis

collection rates per 1 000 population are shown in Figure 8 and Figure 9, respectively.

The WB donation rate (median) was 31.8 donations per 1 000 population [range 21(UK(NI)–76(CY)],

similar to the 2023 rate (34.4).

The apheresis donation rate (median) was 2.5 donations per 1 000 population [range 0.3(CY, EL)–

137(CZ)], similar to the 2023 median (2.6).

4 https://ec.europa.eu/eurostat/ (Population on 1January Y+1 – total)

Haemovigilance Annual Report 2025 15

Figure 8. WB collection rates in Europe per 1 000 population in 2024

Note: LT and SK reported data N/A (shown above in dark grey).

Figure 9. Apheresis collection rates in Europe per 1 000 population in 2024

Note: LT, SK and SE reported data N/A (shown above in dark grey).

Haemovigilance Annual Report 2025 16

1.2.2. Blood/BC issuance and transfusion rates

In 2024, 26 countries (AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, EL, IS, IE, IT, LV, LT, LU, NL, PL, PT,

RO, SK, SI, SE and UK(NI)) provided data for units of blood/BC issued. NO and ES reported N/A for

the number of units issued but provided the number of units transfused. As in previous exercises, it

is considered that all units transfused must have previously been issued, hence the numbers for

units transfused have been included in the total number of units reported as issued.

A total of 20 467 219 units issued of blood/BC were reported in 2024, similar to 2023 (20 824 019).

Figure 10 presents the blood/BC issuance rates per 1 000 population in Europe [range 23(NL)–138

(CY)].

In 2024, the European issuance rate (median) of blood/BC units was determined to be 40.9/1 000

population, marginally lower than the 41.6/1 000 population reported in 2023.

Figure 10. Blood/BC issuance rates in Europe per 1 000 population in 2024

Concerning units of blood/BC transfused, a total of 16 478 412 units were reported by 23 countries

(AT, BE, BG, HR, CY, CZ, DK, EE, FR, DE, EL, IS, IE, IT, LU, NL, NO, PT, RO, SK, ES, SE and UK(NI)). This

value is comparable with 2023 (16 213 234) also reported by 23 countries.

Figure 11 shows the transfusion rates of blood/BC units per 1 000 population in Europe [range

23(NL)–107(CY)].

In 2024, the European blood/BC transfusion rate (median) was determined to be 38.6/1 000

population, the same as reported in 2023.

Haemovigilance Annual Report 2025 17

Figure 11. Blood/BC transfusion rates in Europe per 1 000 population in 2024

Note: FI, LV, LT, PL and SI reported data N/A (shown above in dark grey).

Comparing with 2023, a new transfusion rate was reported for SK (37) and there was a significant

increase for RO (rate 42 vs 23 in 2023).

1.2.3. Recipient rates

According to data reported by 17 countries (BE, BG, HR, CY, CZ, DK, EE, FR, EL, IS, IT, LU, PT, RO, ES,

SE and UK(NI)) 2 530 113 patients were transfused in 2024 regardless of the type of BC, comparable

with 2023 (2 502 392).

Recipient rates per 1 000 population in Europe are displayed in Figure 12 [range 2(UK(NI)–25(CY)].

Haemovigilance Annual Report 2025 18

Figure 12. Recipient rates (regardless of the type of BC) in Europe per 1 000 population in 2024

Note: AT, FI, DE, IE, LV, LT, NL, NO, PL, SK and SI reported data N/A (shown above in dark grey).

The European rate (median) in 2024 was determined to be 9.7 patients transfused/1 000 population,

slightly lower than the 2023 rate (10.2).

Key countries shaping the landscape ➢ Apheresis collection rate in CZ reached 137 per 1 000 population (far above the median 2.5).

➢ CY issuance and transfusion rates were among Europe’s highest (issuance 138 per 1 000; transfusion 107 per

1 000), indicating high per-capita utilisation.

Haemovigilance Annual Report 2025 19

1.3. Overview of volume of activity by type of BC

Overall data collected in 2024 for number of units issued, units transfused and recipients by type

of BC (excluding MTOC) is shown Table 2 and

Table 3.

RBC continue to be the most issued and transfused type of BC by far. In comparison with 2023, there

was a 13% increase in the number of plasma units issued. Regarding number of units transfused,

the values were similar to those recorded in 2023, except for WB.

The number of recipients transfused increased across all types of BC, reflecting sustained clinical

demand.

Table 2. Summary of total number of units issued and transfused by type of BC; 2023 vs. 2024

Table 3. Summary of total number of recipients transfused by type of BC; 2023 vs. 2024

Haemovigilance Annual Report 2025 20

1.4. Country-specific trends (2023 vs. 2024) by type of BC

Considering the demographic data5 of the reporting countries in 2023 and 2024, the transfusion

rates pmp were calculated for each reporting country and for each type of BC (excluding MTOC).

1.4.1. RBC transfusion

Figure 13. RBC transfusion rates pmp per country; 2023 vs. 2024

Note: FI, LV, LT, PL and SI reported data N/A in both 2023 and 2024 (not shown above).

1.4.2. Platelet transfusion

Figure 14. Platelet transfusion rates pmp per country; 2023 vs. 2024

Note: FI, LV, LT, PL and SI reported data N/A in both 2023 and 2024 (not shown above).

5 https://ec.europa.eu/eurostat/ (Population on 1January Y+1 – total)

Haemovigilance Annual Report 2025 21

1.4.3. Plasma transfusion

Figure 15. Plasma transfusion rates pmp per country; 2023 vs. 2024

Note: LV, LT, PL and SI reported data N/A in both 2023 and 2024 (not shown above). FI reported data N/A in 2023.

1.4.4. WB transfusion

Figure 16. WB transfusion rates pmp per country; 2023 vs. 2024

Note: in 2023, AT, HR, CY, DE, EL, IS, IE, LV, LI, LU, NL and UK(NI) reported 0 units and consequently a zero rate (not shown

above). In 2024, AT, BE, HR, CY, EL, IS, NL and UK(NI) reported 0 units of WB transfused and consequently a zero rate (not

shown above).

Haemovigilance Annual Report 2025 22

2 Serious Adverse Reactions in Recipients

(Mandatory)

A serious adverse reaction refers to an unintended response, including a communicable disease, in

the recipient associated with the transfusion of blood/BC that is fatal, life-threatening, disabling or

incapacitating, or which results in, or prolongs, hospitalisation or morbidity.

Insignificant (no harm to the recipient) and non-serious reactions (mild clinical consequences. No

hospitalisation. No anticipated long-term consequence/disability) are not reportable.

SAR are also assessed for imputability which refers to the likelihood that the blood transfusion

directly caused the observed adverse reaction.

The seriousness of a transfusion reaction is evaluated independently of its possible connection with

the transfusion.

The imputability criteria are detailed in the table below:

Table 4. Definition of imputability levels

Imputability Level (IL) Explanation Not Assessable When there is insufficient data for the imputability assessment.

0 Excluded When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.

Unlikely When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood/BC.

1 Possible When the evidence is indeterminate for attributing adverse reaction either to the blood/BC or to alternative causes.

2 Likely, Probable When the evidence is clearly in favour of attributing the adverse reaction to the blood/BC.

3 Certain When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood/BC.

In order to make the boundary between regulatory/statutory obligations and voluntary safety-

monitoring efforts explicit, this chapter includes information only on the number of SAR IL 2-3 in line

with article 5(3)(a) of Directive 2005/61/EC. For information on SAR IL 1, refer to Annex 7. SAR IL 1

(Voluntary).

Key findings

➢ In 2024, a total of 1 360 SAR (IL 2-3) were reported across 16.5 million units of blood/BC transfused. This

represents a 9% decrease in reporting compared to 2023 (1 490 reports), translating to a total SAR (IL 2-3)

rate of 8.3 per 100 000 units transfused.

➢ Platelets consistently show the highest median SAR (IL 2-3) incidence, followed by RBC and plasma.

➢ FNHTR, anaphylaxis/hypersensitivity and TACO remain the three dominant reaction types.

➢ TTI burden decreased: 14 reported (6 less than in 2023). 83% of TTBI cases had pathogen identification (vs

47% in 2023).

➢ 11 fatalities (IL 2-3), the lowest in four years, with RBC involved in 7/11 cases. Fatality proportion: 0.81% of

SAR (IL 2-3).

➢ While general compliance with fatality (IL 2-3) reporting is evident, harmonisation of detail remains

necessary, particularly regarding component preparation, investigations and CAPA documentation.

Haemovigilance Annual Report 2025 23

2.1 Yearly trends (2021–2024)

Figure 17 presents the yearly trends in SAR (imputability of likely/probable or certain) incidence from

2021 to 2024 using two complementary metrics: (i) the total SAR (IL 2-3) incidence per 100 000 units

of blood/BC transfused and (ii) the median of country-specific SAR (IL 2-3) incidence rates (per 100

000 units transfused) across all reporting countries. The first measure provides a region-wide

perspective on the overall burden of SAR (IL 2-3) in transfusion safety, while the second trend

illustrates the typical SAR (IL 2-3) incidence experienced by individual countries.

Figure 17. Yearly trends in SAR (IL 2-3) incidence: total SAR (IL 2-3) incidence/100 000 units transfused and

median per-country SAR (IL 2-3) incidence/100 000 units transfused; 2021–2024

Note 1: total SAR (IL 2-3) incidences are calculated using all reported cases as the numerator and the sum of all reported units

transfused (including countries reporting zero SAR) as the denominator. Countries not reporting denominator data but

reporting SAR contribute to the numerator but not the denominator. Please refer to the completeness dashboard (Annex 3.)

for coverage details.

Note 2: only countries (n) that reported both SAR cases (including zero) and the corresponding number of units of blood/BC

transfused were included in the median per-country SAR incidence calculations.

Between 2021 and 2024, the total SAR (IL 2–3) incidence showed a modest upward trend, increasing

from 7.7 in 2021 to a peak of 9.2 in 2023, before decreasing slightly to 8.3 in 2024. The median

per‑country SAR incidence followed a similar but more variable pattern: rising from 3.7 in 2021 to

4.4 in 2022, dipping again to 3.7 in 2023 and then increasing to 5.2 in 2024. These fluctuations

suggest that while the overall European SAR burden remained relatively stable, country‑level

medians reveal greater year‑to‑year variability, possibly reflecting differences in reporting sensitivity,

national vigilance practices, or small‑number effects in countries with lower transfusion volumes.

Haemovigilance Annual Report 2025 24

2.2 Geographic distribution

The SAR (IL 2-3) incidence rates per 100 000 units of blood/BC transfused across all reporting

countries were determined (Figure 18).

SAR (IL 2-3) incidence in Europe varied from 0 (BG, CY and IS) to 49 (IE), with a median of 5.2

SAR/100 000 units transfused, slightly higher than the 4.4 SAR/100 000 units transfused reported

in 2023.

Figure 18. SAR (IL 2-3) incidence rates per 100 000 units transfused in Europe in 2024

Note: countries (FI, LV, LT, PL and SI) that reported SAR cases but reported N/A for the number of units of blood/BC

transfused (so incidence could not be calculated) are shown in dark grey.

Comparing with 2023, there was a significant increase for LU and IE (27 and 49 vs 0 and 19,

respectively). Additionally, NL, HR and SE reported moderate increases (15, 5 and 4 vs 12, 3 and 2

respectively) whereas AT, IT, PT and ES showed decreased incidence rates.

Key countries shaping the SAR picture ➢ IE reported the highest SAR (IL 2-3) incidence rate (49 per 100 000 units transfused).

Haemovigilance Annual Report 2025 25

2.3 Yearly trends (2021–2024) by type of BC

2.3.1 SAR (IL 2-3)

Figure 19 presents the yearly trends in the median per-country SAR (IL 2-3) incidence per 100 000

units transfused from 2021 to 2024 for each type of BC (excluding WB and MTOC).

Figure 19. Yearly trendsin SAR (IL 2-3) incidence (median per-country) per 100 000 units transfused of

platelets, plasma and RBC; 2021–2024

Note 1: only countries (n) that reported both SAR cases (including zero) and the corresponding number of units of BC

transfused were included in the median per-country SAR incidence calculations.

Note 2: median SAR incidence in WB is not shown above as only one country reported throughout the period (2021: 2 cases;

2022: 0; 2023: 1 case; 2024: 2 cases).

As consistently observed in prior years, platelet transfusions carry the highest median per-country

SAR (IL 2-3) incidence rate, substantially exceeding that of RBC and plasma components. This is

biologically expected given the immunogenically complex nature of platelet products.

Moreover, the RBC SAR (IL 2-3) rate has remained comparatively stable, while plasma SAR (IL 2-3)

rate is exhibiting a modest upward trend.

2.3.2 Fatalities (IL 2-3)

Transfusion-associated fatalities remain exceptionally rare when measured against the sheer

volume of blood/BC utilised. Among the transfusion-related deaths, the majority were due to the

transfusion of RBC (largely proportional to their dominance in issuance and transfusion volumes),

followed by platelets and then MTOC (Figure 20).

In 2024, the risk of death related to transfusion in Europe was 1 in approximately 1.5 million units of

blood/BC transfused. Alternatively, this corresponds to a transfusion‑related mortality rate of

approximately 0.06 per 100 000 units transfused.

Haemovigilance Annual Report 2025 26

Figure 20. Summary of total number of fatalities (IL 2-3) by type of BC; 2021–2024

Note: no fatalities reported in WB.

2.4 Country-specific trends (2023 vs. 2024) by type of BC

SAR (IL 2-3)incidence rates per 100 000 units transfused per country for each type of BC (excluding

MTOC) in 2023 and 2024 is presented in Table 5.

Table 5. SAR (IL 2-3) incidence rates/100 000 units (RBC, platelets or plasma) transfused per country; 2023

vs. 2024

Note 1: CY and IS reported zero SAR across the different types of BC in both 2023 and 2024 (not shown above).

Note 2: SAR incidence rates in WB not shown above (2023 (IT): 1 SAR reported; 2024 (NO): 2 SAR reported).

Note 3: *in 2023, SK reported N/A for number of units transfused so incidence could not be calculated.

Note 4: highlighted in red are changes that represent a potential real concern. These countries show multiple SARs (not just

1–2), large transfusion denominators (so rates are stable), sharp increases beyond what small‑number variation can

explain. Highlighted in green are true improvements not strongly influenced by small denominators or low SAR counts.

Haemovigilance Annual Report 2025 27

The comparative data for countries which also reported SAR (IL 2-3) but were missing denominator

data (resulting in the impossibility of calculating the incidence rate) are shown in Table 7.

Table 6. Number ofSAR (IL 2-3) per country reporting missing denominator data in RBC, platelets and

plasma; 2023 vs. 2024

2.5 Overview of SAR (IL 2-3) and fatalities (IL 2-3) by type of BC

Overall data collected in 2024 for number of SAR (IL 2-3) and fatalities (IL 2-3) by type of BC are

shown in Table 7.

In 2024, the total number of SAR (IL 2-3) reported was 1 360, slightly lower than in 2023. Of the total

1 360 SAR (IL 2-3) reported, 77% were attributed to IL 2 and 23% to IL 3 (vs 75% and 25% in 2023,

respectively).

Eleven fatalities (IL 2-3) were reported in recipients in 2024, ten less than in 2023.

Table 7. Summary of total number of SAR (IL 2-3) and fatalities (IL 2-3) by type of BC; 2023 vs. 2024

Haemovigilance Annual Report 2025 28

2.5.1 SAR (IL 2-3) by type of BC per country

The distribution of number of SAR (IL 2-3) by type of BC per reporting country is shown in Figure 21.

Figure 21. Number of SAR (IL 2-3) by type of BC per country in 2024

Note 1: also 2 SAR for WB from NO were reported (not shown above).

Note2: BG, CY and IS reported zero SAR (not shown above).

2.5.2 Fatalities (IL 2-3) by type of BC per country

Regarding the eleven fatalities (IL 2-3) reported, the country reporting them is detailed in Table 8.

Table 8. Summary of total number of fatalities (IL 2-3) by type of BC per reporting country in 2024

Note: zero fatalities reported in plasma and WB.

Haemovigilance Annual Report 2025 29

2.6 Yearly trends (2021–2024) by type of reaction

Transfusion reactions are classified as shown in Table 9. International Society of Blood Transfusion

(ISBT) definitions are used (except for transfusion transmitted infections – see 2.7.2).

Refer to Annex 4. Definitions of the reportable types of transfusable reactions.

Table 9. Types of reportable transfusion reactions

Immunologically related SAR Cardiovascular and

metabolic problems

Transfusion-

transmitted

infection (TTI)

• Transfusion-related acute lung injury (TRALI)

• Anaphylaxis/hypersensitivity

• Febrile non-haemolytic transfusion reaction (FNHTR)

• Immunological haemolysis (due to ABO incompatibility/due to other alloantibody)

• Post-transfusion purpura (PTP)

• Transfusion-associated graft-versus-host disease (Ta-GvHD)

---------------------------------------------------------------------------------------- Non-immunological haemolysis

• Transfusion-associated cardiovascular overload (TACO)

• Hypotensive transfusion reaction

• Transfusion-associated dyspnoea (TAD)

• Bacterial (TTBI)

• Viral (TTVI) o HBV, HCV, HIV-1/2,

other

• Parasitical (TTPI) o malaria, other

• Fungal (TTFI)

• Prion (TTPRI)

Other (reactions which do not meet the criteria for a defined category)

2.6.1 SAR (IL 2-3)

Table 10 shows the percentages of total SAR (IL 2-3) by the main reaction types and Figure 22 shows

the trend in reporting from 2021 to 2024.

Table 10. Percentages of total SAR (IL 2-3) by the main reaction types; 2021–2024

Haemovigilance Annual Report 2025 30

Figure 22. Yearly trends in percentage of total SAR (IL 2-3) by the main reaction types; 2021–2024

This distribution by the main reaction types has remained largely consistent across the 2021–2024

period, confirming that FNHTR and anaphylaxis/hypersensitivity continue to dominate the European

haemovigilance landscape. These group of unpredictable and largely unpreventable reactions

accounted for 52% of all SAR (IL 2-3) in 2024.

As been noted in UK’s Serious Hazards of Transfusion (SHOT) recent reports [2] harm can be

minimised by ensuring that treatment given and investigations performed are correctly targeted to

the type of reaction. This means using the patient’s symptoms and signs to distinguish febrile from

allergic reactions.

TACO as the third most frequent type of reaction keeps increasing gradually.

Unlike FNHTR or antibody-mediated reactions, TACO is a largely preventable complication of

transfusion practice. Haemovigilance signals derived from SHOT indicate that TACO is a direct

physiological consequence of administering fluid volume at a rate or volume that a compromised

cardiopulmonary system cannot process. SHOT has heavily emphasized the need for pre-

transfusion TACO risk assessments. [3]

The persistent occurrence of TACO indicates that challenges remain in assessing patient risk and

selecting appropriate transfusion parameters, even though the blood product itself is safe.

2.6.2 Fatalities (IL 2-3)

Table 11 shows the number of transfusion-related deaths by type of reaction from 2021 to 2024.

Haemovigilance Annual Report 2025 31

Table 11. Summary of total number of fatalities (IL 2-3) by type of reaction; 2021–2024

As shown in Table 11, the number of fatalities (IL 2-3) were at their lowest in 2024, comparing to

previous years.

Overall, in the 2021–2024 period, immunological haemolysis, TACO and TRALI were the leading

causes of deaths, with a total of 32, 18 and 15 cases, respectively.

2.7 Overview of SAR (IL 2-3) and fatalities (IL 2-3) by type of

reaction

2.7.1 SAR (IL 2-3)

As shown previously in Table 10, in 2024, FNHTR was the most prevalent type of reaction (26.1%)

followed by anaphylaxis/hypersensitivity (25.7%) and TACO (16.7%).

Table 12. Summary of total number of SAR (IL 2-3) by type of reaction; 2023 vs. 2024

Note: zero SAR reported for Ta-GvHD, TTFI and TTPRI in both 2023 and 2024.

In general, the number of cases reported across the different types of reactions decreased in

comparison with 2023, apart from TACO and TTVI, which increased slightly (Table 12).

Haemovigilance Annual Report 2025 32

Figure 23 shows the distribution of SAR (IL 2-3) classified as ‘other’.

Figure 23. Distribution of SAR (IL 2-3) classified as ‘other’ in 2024

A detailed summary of the top 5 transfusion reaction types by type of BC for 2023 vs. 2024 is

displayed in Table 13 and Table 14.

Table 13. Summary of number of SAR (IL 2-3) (excluding fatalities) by the top 5 reaction types in WB, RBC

and platelets; 2023 vs. 2024

Note: a) due to ABO incompatibility; b) due to other alloantibody

As presented in Table 13, overall, there was a reduction in the number of SAR (IL 2-3) observed in

the top 5 reaction types in WB, RBC and platelets. Nevertheless, there were 30 more TACO cases

reported in RBC and 39 more FNHTR cases reported in platelets.

Haemovigilance Annual Report 2025 33

Table 14. Summary of SAR (IL 2-3) (excluding fatalities) by the top 5 reaction types in plasma and MTOC;

2023 vs. 2024

Note: a) due to ABO incompatibility; b) due to other alloantibody.

2.7.2 Transfusion-Transmitted Infections (TTIs)

As per SHOT definition, a case is classified as a TTI if the investigation revealed:

The recipient had evidence of infection post-transfusion with BC, there was no evidence of infection

prior to transfusion, no evidence of an alternative source of infection and:

• either at least one component received by the infected recipient was donated by a donor who

had evidence of the same transmissible infection.

• or at least one component received by the infected recipient was shown to contain the agent

of infection.

Overall, the total number of confirmed TTIs (IL 2-3) decreased substantially, from 20 in 2023 to 14

in 2024, driven primarily by a marked reduction in TTBI (Table 15).

Table 15. Summary of TTIs (IL 2-3) by type of TTI; 2023 vs. 2024

Note: zero TTFI and TTPRI cases reported in both 2023 and 2024.

As presented in Table 16, RBC‑related TTIs declined across all infection categories, with a notable

reduction in TTBI (-6). In contrast, TTIs associated with platelets increased slightly, rising from 8 to

10, mainly due to an increase in TTVI (+5) despite reductions in bacterial TTIs (-3). Although absolute

numbers remain small, this shift highlights platelets as a continuing area of vigilance.

Haemovigilance Annual Report 2025 34

Table 16. Summary of TTIs (IL 2-3) by type of TTI and by type of BC; 2023 vs. 2024

Note 1: zero TTFI and TTPRI cases reported in both 2023 and 2024.

Note 2: zero TTIs reported in WB in both 2023 and 2024.

The exact infectious pathogen was provided in 5 out of 6 (83%) TTBI cases reported (Table 17), a

notable improvement from 47% in 2023. This improvement in pathogen characterisation reflects the

value of standardised post-investigation reporting and should be encouraged across all reporting

countries. Where pathogen identification remains incomplete, reporting establishments are

encouraged to document at minimum the genus and route of contamination, as this information is

essential for corrective action and benchmarking against international contamination databases

such as the European Centre for Disease Prevention and Control (ECDC) pathogen surveillance

systems and ISBT's bacterial contamination working group data.

Table 17. Summary of the infectious pathogen reported in TTBIs by type of BC per country in 2024

Note: the Spanish case occurred in 2023, but the investigation was only finalised in 2024.

Regarding TTVIs, the exact infectious pathogen was provided in all reported cases (the same as in

2023). As presented in Table 18, of the 8 TTVIs, five were reported in platelets, two in RBC and one

in MTOC.

Table 18. Summary of the infectious pathogen reported in TTVIs by type of BC per country in 2024

Haemovigilance Annual Report 2025 35

2.7.3 Fatalities (IL 2-3)

As mentioned previously, five countries (BE, FI, FR, DE and NO) reported a total of 11 fatalities (IL 2-

3) in recipients in 2024. Of these fatalities, six were assigned IL2 and five IL3. The type of reaction

associated with these fatalities is captured in Table 19 and the comparison with 2023 data is shown

in Table 20.

Table 19. Summary of number of fatalities by type of reaction and by IL 2 or 3 in 2024

Table 20. Summary of number of fatalities (IL 2-3) by type of reaction and by type of BC; 2023 vs. 2024

Note: no fatalities were reported in plasma and WB in both 2023 and 2024.

As shown in Table 20, in comparison with 2023, 2024 saw a reduction in fatalities associated with

both TACO and immunological haemolysis, namely in RBC. This has contributed to the overall

reduction in recipient fatalities from 21 to 11.

Haemovigilance Annual Report 2025 36

2.8 Fatalities (IL 2-3) in recipients – case studies

The Common Approach, 2025 edition [1], states: “Concerning reports where an SAR is confirmed to

be fatal, any relevant information should be reported, such as:

(i) a brief description of patient details (if possible: gender, age, initial illness, clinical indications for

transfusion etc.);

(ii) a brief description of the occurrences that led to the fatality. In the case of a TTI, state the

pathogen (species) which was demonstrated (NEW);

(iii) a list of transfused units of blood/BC; for each unit, any relevant information regarding the

preparation of the implicated component(s) (leucodepletion, apheresis...);

(iv) the conclusions and follow-up actions (corrective and preventive), if appropriate.”

Overall, the quality and completeness of fatality reporting in 2024 varied significantly across

countries. Most reports contained adequate clinical descriptions. However, the level of detail

regarding component preparation, transfusion chronology, root cause assessment and

corrective/preventive actions was not uniform.

Several countries provided high‑quality narratives that met all (or nearly all) Common Approach

requirements, including clear patient history, detailed timelines, component‑specific technical

information and explicit conclusions. Other reports lacked essential elements, particularly

transfused component characteristics, preparation details and documented corrective and

preventive actions (CAPA). The variability in reporting may suggest that, while many NCA have

well‑established fatality investigation pathways, others may benefit from further guidance and

harmonisation to ensure consistent adherence to the Common Approach.

For transparency and learning, a small number of representative cases are then presented below to

support clinical learning across the European haemovigilance network.

Case 1: Severe Anaphylaxis (RBC), IL2

• (i) Patient details: 66-year-old patient, with a following medical history: diabetes type II, hypertension, heart

disease, endocarditis (aortic valve replacement), cerebral vascular accident and chronic obstructive pulmonary

disease; Chronic alcoholism, active smoking.

• (ii) Events leading to the fatality: He was admitted to hospital with anaemia due to gastrointestinal bleeding

(melena), of unspecified cause. Hb was 72 g/L. Immediate clinical manifestations from the first ml transfused with

facial oedema, macroglossia, respiratory discomfort and grunting without skin manifestations. Immediate medical

management of the upper airway obstruction was unsuccessful, followed by rescue tracheostomy (because

intubation had failed) and continued ventilation and cardiopulmonary resuscitation for 30 minutes without

success.

• (iii) List of transfused units: One RBC prescribed.

• Investigation: No known allergic history, eczema of both legs. The patient had already been transfused without

adverse reactions. Post mortem biomarkers showed histamine >100 nmol/L (standard <10 nmol/L) and tryptase

10.1 µg/L (below 11 µg/L but above the 95th percentile of 8.4 µg/L). The donor of RBC is a regular donor. No

medication taken. No adverse reaction had occurred with BC derived from other donations.

• (iv) Conclusions and Follow-up actions: Hypoxia would appear to be the main cause of the cardiorespiratory

arrest.

Key compliance strengths: Full patient history; biomarker data; donor history

Haemovigilance Annual Report 2025 37

Case 2: Other (delayed haemolytic transfusion reaction (DHTR)), RBC, IL3

• (i) Patient details: A 23-year-old patient with homozygous sickle cell disease, treated with hydroxyurea (baseline

Hb 80g/L) and Oxbryta (voxelotor) since July 2023, with a following medical history: multiples vaso-occlusives

crises, acute thoracic syndrome, cerebral vasculopathy, cholecystitis and osteomyelitis. Transfusion history with in

2023, no antibody identified. He was receiving several doses of rituximab. The last dose was in January 2024. He

was transfused in March 2024 before a haemopoietic stem cell transplantation with two phenotyped and matched

RBC, each preceded by a blood exchange.

• (ii) Events leading to the fatality: At day 5 after transfusion, onset of vaso-occlusive crisis of both hips, and Hb

level was 94 g/L with biological signs of haemolysis (intermediate DHTR risk), no new antibodies identified. Hb A

3.3%, Hb S 63.4%. He was hospitalised in the continuous medical monitoring department for further management.

At day 6 after transfusion, in the morning, clinical deterioration, renal failure with acidosis and severe

hyperkalaemia. Treated with Eculizumab and renal dialysis. Unfavourable neurological and respiratory outcome

(acute respiratory distress) requiring intubation in the afternoon. Thoracic angioscan showed bilateral parenchymal

condensation. Cardiogenic shock (right heart) developed during the night, with no response to vasopressor amines.

Haemolysis parameters progressively worsened with increasing renal failure, and the Hb level rose to 50 g/L. At

day 7 after transfusion, there was a sudden haemodynamic deterioration with severe hypotension. A follow-up

transthoracic ultrasound revealed a major acute pulmonary heart with systolic failure of the left ventricle. The

patient died a few hours later in multivisceral failure despite maximum resuscitation.

• (iii) List of transfused units: Two phenotyped and matched RBC, each preceded by a blood exchange.

• (iv) Conclusions and Follow-up actions: (not mentioned)

Points for consideration: Do hospitals have sickle cell disease-specific transfusion protocols? and are they being

applied?

It also illustrates the difficulty of attributing causality when no new antibodies are detected, which has direct

implications for imputability scoring.

Case 3: Suspected TACO (RBC), IL2

• (i) Patient details: (M, 84 years): History: Patient known by palliative support team: AML + aortic valve stenosis.

• (ii) Events leading to the fatality:

o General malaise (palliative; AML)

o Hypertension: before transfusion 162/66, after 15' 173/81, stop transfusion at 12:21 213/86

o Temp: before transfusion 37°C, after 15' 36.9°C, stop transfusion 37.8°C + shivering

o Shivering fever again in the evening: temp at 18:00: 38.2°C and 19:25 38.4°C

o At 20:00: oxygen administration (sat 87%)

o At 20:45: patient deceased

• (iii) List of transfused units: (not mentioned)

• (iv) Conclusions and Follow-up actions: Still haemolysis? Acute pulmonary edema? Due to underlying disease?

Key deficiencies: ✖ Component details missing; ✖ Limited clinical narrative: hypertension and shivering described,

but no detailed examination findings, fluid balance, imaging or lab outcomes; ✖ No CAPA documented.

Points for consideration: TACO is typically preventable, but insufficient information prevents drawing conclusions

about transfusion rate, volume or monitoring. It also illustrates the blurred line between TACO, TAD, and disease

progression.

Haemovigilance Annual Report 2025 38

Case 4: Hypotensive transfusion reaction (RBC), IL2

Female (80 years old) had acute bleeding and also suspected to have septic shock. Patient died less than 24 hours

from the transfusion. Patient's IgA levels were found to be normal. Microbial culture was performed on the remains

of the RBC unit and there was no growth. It is unlikely that the patient's symptoms were due to contaminated RBC

unit.

Key deficiencies: ✖ Very brief description, insufficient detail on transfusion sequence or clinical deterioration;

✖ No transfused component preparation details; ✖ No CAPA documented.

Point for consideration: This case highlights how missing detail prevents proper classification (e.g., distinguishing

between septic shock, hypotension or coexisting clinical causes).

Haemovigilance Annual Report 2025 39

3 Serious Adverse Events (Mandatory)

Only adverse events (AE) considered serious, i.e., when they may put in danger blood donors or

recipients of blood/BC, or they may have a negative impact on blood donation or on transfusion of

patients are reportable to the EC.

Early identification, analysis and evaluation of SAE provide an up-to-date overall picture of safety in

the transfusion chain and of the nature and dimension of the expected risks. Investigation of these

events can provide additional information about the causes of avoidable transfusion incidents and

show where improvements are necessary and possible.

Deviations from standard operating procedures (SOPs) in reporting establishments, or other AE

which have implications for the quality and safety of blood/BC, should be reported to the EC only

when one or more of the criteria described in Table 21 applies.

Table 21. Criteria for inclusion of SAE

Scenario Examples

Inappropriate blood/BC have

been issued/distributed for

use, even if not used

- BC distributed for use with incorrect blood group labels, - BC distributed for use without the mandatory donor testing results, - BC issued with incorrect cross-matching information, - BC distributed for use despite a post-donation notification from the donor implying a disease transmission risk, - BC distributed/issued for use despite having been stored at temperatures outside the required range, - BC issued by the hospital blood bank (HBB) without specific characteristics

requested by the treating physician (e.g., irradiation, cytomegalovirus (CMV)

negative).

The AE resulted in loss of

any irreplaceable highly

matched (i.e. recipient

specific) blood/BC

- BC prepared for a patient with highly specific and urgent needs lost due to a storage or processing error, - BC of a very rare group collected for a specific recipient and lost due to a storage or processing error.

The AE resulted in the loss of a significant quantity of unmatched blood/BC – a significant quantity is considered a loss that will have a negative impact (delay or cancellation) on treatment or surgery

- in a BE, an undetected cold-room breakdown with the consequent discard of number of red cell concentrates (RCC) creating a problem to respond to requests for RCC from hospitals, - a failure of the virology testing equipment results in 50% of a large blood

establishment (BE) (supplying many hospitals) platelet stock expiring without being

cleared for issue.

Key findings

➢ In 2024, 4 764 SAE were reported, a 108% increase compared to the 2 294 SAE recorded in 2023, driven

almost entirely by Romania (67% of all SAE).

➢ European total SAE incidence doubled to 19.5 per 100 000 units processed, up from 9.7 in 2023, once again,

driven by Romania’s dataset. However, the median per-country value was consistent with previous years.

➢ Activity steps most associated with SAE: storage (42%), WB collection (17%) and processing (15%).

➢ Root cause pattern shifted: component defect (60%) overtook human error (14%) due to Romanian reporting.

Furthermore, a substantial proportion of its records contained insufficient detail which severely limits

qualitative analysis. (NOTE: excluding Romania, human error remained the leading cause (38%)).

➢ Type of human error: 78% of human error SAE were incorrect decisions/omissions while following correct

procedures, rather than knowingly following wrong procedures (5%); most occurred at issue and donor

selection.

Haemovigilance Annual Report 2025 40

The AE could have implications for other patients or donors because of shared practices, services, supplies or donors (e.g., repeated event inside or outside the BE/HBB)

- a defect is detected in a haemoglobin testing device known to be used by other BE – no harm caused to donors due to parallel testing by a different method.

The AE could significantly impact the blood transfusion system (e.g., by jeopardising the confidence of blood donors or recipients)

- confidential donor information is accidentally made publicly accessible, - donations are collected, in error, from underage donors.

The term "near miss event"6 is not defined in the Blood Directive but is a commonly used term. A

near-miss is functionally a free lesson, an error that occurred in the chain but was caught by chance

or secondary checks right before patient harm occurred. If ‘near miss events’ meet the criteria listed

in the table above, they are reportable as SAE.

When a SAE results in a reportable SAR in a blood recipient or donor, only the SAR, not the SAE,

should be reported.

3.1 Yearly trends (2021–2024)

SAE occur at all stages of the transfusion cycle, from donor selection to clinical services, but the

only available denominator is number of units of blood/BC processed, which is not optimal. Due to

the lack of appropriate data, SAE incidence rates were calculated in relation to number of units of

blood/BC processed, irrespective of where the events were identified/occurred.

Figure 24 presents the yearly trends in SAE incidence from 2021 to 2024 using two complementary

metrics: (i) total SAE incidence per 100 000 units of blood/BC processed and (ii) the median of

country-specific SAE incidence rates (per 100 000 units processed) across all reporting countries.

The first measure provides a region-wide perspective on the safety and efficiency of the whole

transfusion chain, while the second trend illustrates the typical SAE incidence experienced by

individual countries.

6 According to SHOT, near miss events are "an error or deviation from standard procedures or policies that is discovered before the start of the transfusion

and that could have led to a wrong transfusion or a reaction in a recipient if transfusion had taken place.” https://www.shotuk.org/reporting/ (accessed 31 March 2026)

Haemovigilance Annual Report 2025 41

Figure 24. Yearly trends in SAE incidence: total SAE incidence/100 000 units processed and median per-

country SAE incidence/100 000 units processed; 2021–2024

Note 1: total SAE incidences are calculated using all reported cases as the numerator and the sum of all reported units

processed (including countries reporting zero SAE) as the denominator. Countries not reporting denominator data but

reporting SAE contribute to the numerator but not the denominator. Please refer to the completeness dashboard (Annex 3.)

for coverage details.

Note 2: only countries (n) that reported both SAE cases (including zero) and the corresponding number of units of blood/BC

processed were included in the median per-country SAE incidence calculations.

Figure 24 shows that between 2021 and 2023, both the total and median per-country SAE incidence

rates were generally stable. The sharp increase in 2024, with the total incidence more than doubling

relative to 2023, is attributable to the SAE dataset submitted by Romania. When examined at the

median country level, SAE patterns remained stable and consistent with previous years.

When Romania's contribution is excluded, the total SAE incidence for 2024 falls from 19.5 to 6.4 per

100 000 units processed, a figure lower than the 2023 total of 9.7, suggesting no deterioration in the

overall safety performance.

3.2 Geographic distribution

24 423 977 blood units were processed in 2024 according to data provided by 28 countries. This

was a slight increase in comparison with the previous year (23 700 556 reported by 26 countries).

A total of 4 764 SAE were reported in 2023 by 25 countries (AT, BE, HR, CY, CZ, DK, EE, FI, FR, DE, EL,

IE, IT, LV, LU, NL, NO, PL, PT, RO, SK, SI, ES, SE and UK(NI)), representing a 108% increase in

comparison with 2023 (2 294). This alarmingly shift can be explained by Romania’s data, which

alone accounts for 67% of the total number of SAE reported.

SAE incidence rates per 100 000 units of blood/BC processed across all reporting countries were

determined (Figure 25). There was a wide range of SAE incidence rates, with the lowest being 0 (BG,

IS and LT) and the highest reaching 332 (RO). The median was 6.4 SAE/100 000 units processed.

Haemovigilance Annual Report 2025 42

Figure 25. SAE incidence rates per 100 000 units processed in Europe in 2024

3.3 Country-specific trends (2023 vs. 2024)

Figure 26 compares the SAE incidence rates (per 100 000 units processed) per country in 2024 with

2023.

Figure 26. SAE incidence rates per 100 000 units processed per country; 2023 vs. 2024

As presented in Figure 26, Romania reported the highest incidence rate (vs. N/A in 2023).

Furthermore, there was a significant rate increase for EE and SI in comparison with 2023, while BE,

IE and SK showed a clear improvement.

Haemovigilance Annual Report 2025 43

3.3.1 Overview of SAE per country

The number of SAE reported per country is shown in Figure 27.

Figure 27. Number of SAE per country in 2024

Note: outlier RO (SAE= 3 194) not shown above.

3.4 Overview of SAE by activity step

Clusters of errors at a specific point in the transfusion chain are indicative of particularly critical

process points. As per the Common Approach, 2025 edition [1], there are nine crucial points

(activity steps) where errors might happen in the transfusion process. Their definitions are

explained in the table below.

Key countries shaping process safety picture ➢ RO reported an extremely high SAE incidence of 332 per 100 000 units processed.

➢ Comment RO: “In 2023, there were limitations in our reporting system that led to underreporting or incomplete

documentation of events. For this reason, “N/A” was indicated for that year. Starting in 2024, we implemented a

revised SAE reporting protocol, along with additional training sessions for personnel involved in the identification

and reporting of adverse events. The reporting criteria have been broadened to include cases previously

considered minor or ambiguous, in alignment with updated haemovigilance recommendations.”

Haemovigilance Annual Report 2025 44

Table 22. Definitions of activity steps for SAE

Activity Step Definition

1. Donor selection the evaluation carried out to avoid collecting blood from donors with increased risk of

complications and to avoid risk of TTI or other adverse reactions in the recipient.

(exclusive to BE)

2. WB and apheresis

collection

the act of collection of WB or apheresis donations. (exclusive to BE)

3. Testing the act of testing blood donations to meet the requirements of Directive 2002/98/EC

Annex IV, as well as supplementary national requirements. This includes donor testing

as well as BC testing. (exclusive to BE)

4. Processing the process of transforming donations of WB and apheresis donations into issuable

components intended for transfusion. This also involves secondary processing such

as irradiation. (exclusive to BE)

5. Storage the act of storing blood/BC at BE or HBB and the written SOPs to ensure maintenance

of quality and safety from the time blood/BC are released from a BE and distributed to

an HBB. (exclusive to BE)

6. Distribution the act of delivery of blood/BC to other BE, HBB and manufacturers of blood and

plasma derived products. It does not include the issuing of blood/BC for transfusion.

(exclusive to BE)

7. Component selection the selection of the appropriate component based on the recipient’s needs. This

occurs before issue. (BE or HBB)

8. Compatibility

testing/Cross-matching

procedures of blood group serological investigations of the intended recipient and

compatibility testing with donor red cells, carried out before transfusion.

It includes procedures for (electronic) compatibility verification in facilities where

“Type and Screen” is used for eligible patients. (BE or HBB)

9. Issue the process of linking the correctly selected component to the correct patient and

patient records and the labelling of that component, to maintain traceability. (BE or

HBB)

Other any other activity or parameter in the process that can affect the quality and safety of

the component that may harm a patient.

EU legislation7 on blood applies up to the issueof the BC for transfusion, after which the

clinical legal sphere applies. Bedside treatment prior to and after transfusion is therefore the

exclusive responsibility of MS.

However, practical experience demonstrates that this boundary can be blurred because the two

legal spheres are closely interconnected in operational terms. For example, BC may be received

by clinical staff at the hospital and stored minutes or even hours prior to the transfusion in a

fridge next to the clinical area that is monitored by the HBB. These dark grey zones cause

uncertainty over which SAE should be reported under the Blood Directives.

Storage, even after issue to a clinical area, falls within the scope of the Blood Directive and any

SAE that occur during this time are therefore reportable. For example, a unit of blood may be

stored incorrectly on a ward and then returned to the blood fridge for use at a later time, or a

unit of blood may be incorrectly packaged for distribution to another hospital when a patient is

transferred.

7 Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events.

Haemovigilance Annual Report 2025 45

SAE which are not reportable include:

• an incorrect result of compatibility testing performed by the BE/HBB due to a misidentification

of the recipient's blood sample (e.g., wrong blood in tube (WBIT) from a clinical area and

detected in the lab);

• correctly cross-matched and labelled BC that are issued by the HBB for the correct patient and

transfused to the wrong patient.

In 2024, the most common SAE occurred during storage (42%), followed by WB collection (17%) and

processing (15%) as shown in Figure 28. This distribution is quite different from the previous year

where SAE classified as ‘other’ were the most frequent (37%), followed by those attributed to storage

(16%) and issue (9%).

Figure 28. Percentage distribution of SAE by activity step in 2024

As shown in Table 23, a dramatic increase was observed in the number of SAE assigned to storage,

primarily driven by Romania’s data which accounts for 95% of the total number of SAE associated

with storage.

Furthermore, 218 SAE were classified as ‘other’, representing a 74% drop (equivalent to 622 less

reports) in comparison with 2023. This significant improvement demonstrates NCA’s effort in

promoting uniform classification.

Haemovigilance Annual Report 2025 46

Table 23. Summary of total number of SAE by activity step; 2023 vs. 2024

Of the total 4 764 SAE reported, 218 were assigned to the activity step ‘other’. Details of these entries

are presented in Figure 29. In addition, the distribution per country of SAE classified as ‘other’ vs the

nine defined activity steps is presented in Figure 30.

Figure 29. Distribution of SAE classified with the activity step ‘other’ in 2024

Haemovigilance Annual Report 2025 47

Figure 30. Percentage distribution (and absolute numbers) of SAE classified as ‘other’ vs the nine defined

activity steps per reporting country in 2024

In order to continuing incentivizing reclassification, the per-country ‘other’ share 2023 vs. 2024 is

presented in Table 24.

Table 24. Percentage of SAE classified with activity step ‘other’ per reporting country; 2023 vs. 2024

3.5 Yearly trends by specification (2021–2024)

According to the Common Approach, 2025 edition [1], the specifications (i.e. error causes) that can

be associated with a specific event include component defect, equipment failure, materials, system

failure, human error and other. Their definitions are explained in the table below.

Haemovigilance Annual Report 2025 48

Table 25. Definitions of specifications (causes) for SAE

Specification Definition

Component defect when the blood/BC that has been issued for use does not meet the quality and safety

requirements set in Annex V of the Directive 2004/33/EC due to an undetectable

parameter.

Equipment failure when it was caused by any instruments or machinery that did not function as required at any stage from the collection to the distribution of blood and BC.

➢ if the equipment failed because of inappropriate use, or the failure was not detected/ prevented by incorrect human action, these should be reported as human error.

➢ failures of medical devices, whether or not they met the criteria for SAE notification, should be reported under medical device legislation.

Materials when it was caused by any material (bags, preservation solutions, etc.) from

collection to distribution of blood/BC.

➢ if the SAE was caused by inaccurate human handling of the material, these

should be reported as human error.

System failure when the quality management system fails. Type of error:

• insufficient training or education

• high workload or pressure, incompetent staffing or insufficient skill-mixes of staffing

• inadequate processes, procedures or documentation

• other, or no information to assign the above options

Human error when it resulted from an inappropriate or undesirable human decision or behaviour

that reduces, or has the potential of reducing, effectiveness, quality, safety, or system

performance.

SAE should only be categorised as human error once investigation has ruled out

failure of the system. Type of error:

• incorrect decision or omission following the correct procedure

• following the wrong procedure

• other, or no information to assign the above options

Other when it cannot be classified in the specifications listed above.

Figure 31 shows the yearly trends in percentage of total SAE by type of specification from 2021 to

2024.

Figure 31. Yearly trends in percentage of total SAE by specification; 2021–2024

Haemovigilance Annual Report 2025 49

From 2021 to 2023, human error consistently represented the dominant root cause category,

accounting for approximately 40–50% of all SAE per year. This is consistent with international

benchmarking data: the SHOT annual report [2] has repeatedly identified human factors, particularly

incorrect decisions, omissions in procedure and communication failures, as the primary driver of

near-miss and serious transfusion events.

Equipment failure and component defect maintained relatively stable and comparatively lower

shares over the same period. The clear change of pattern in 2024, with component defect rising to

60% and human error falling to 14%, is almost entirely attributable to the Romanian’s data, which

classifies the large majority of its reported SAE under component defect and equipment failure

categories. Without Romania's contribution, the 2024 specification distribution would be

substantially consistent with prior years, reinforcing the conclusion that this shift reflects a reporting

system difference rather than a genuine European-wide change in root cause patterns.

3.6 Overview of SAE by specification

As presented in Figure 32 and Table 26, in 2024, the most predominant root causes identified were

component defect (60%), human error (14%) and equipment failure (11%). This picture differs

significantly from the previous year — human error (42%), equipment failure (17%) and component

defect (16%). As already mentioned, the main reason for this change is due to the data reported by

Romania which accounts for 92% of the total number of SAE associated with component defect and

80% of the total number of SAE associated with equipment failure.

Excluding Romania's contribution, the distribution of SAE by specification in 2024 would revert to a

pattern closely aligned with 2023: human error would remain the predominant root cause (38%),

followed by ‘other’ (18%), system failure (15%) and component defect (14%).

Figure 32. Percentage distribution of SAE by specification in 2024

Haemovigilance Annual Report 2025 50

Table 26. Summary of total number of SAE by specification; 2023 vs. 2024

Figure 33 disaggregates the root cause (specification) profile within each activity step, revealing

important patterns in where different types of failure concentrate. Human error is predominant in

the issue and component selection steps, consistent with the well-established vulnerability of these

process points to staff identification errors. Component defect concentrates in storage, WB

collection and processing steps, while equipment failure is distributed across storage and

processing.

Figure 33. Distribution of SAE for the defined activity steps by specification in 2024

Of the 218 SAE assigned to the 'other' activity step, the majority were attributed to human error and

system failure causes, suggesting that many of these events involve process gaps that span multiple

defined activity steps or fall outside the canonical transfusion chain defined in the Blood Directive

framework (Figure 34).

Haemovigilance Annual Report 2025 51

Figure 34. Distribution of SAE assigned to ‘other’ activity step entries by specification in 2024

Regarding events assigned the cause ‘human error’, the specific type of error/failure was also

reported (Figure 35 and Table 27). In 2024, 78% of events reported were related to staff making an

incorrect decision or skipping steps in a process (vs 75% in 2023), whereas only 5% were related to

staff having knowingly followed the wrong procedure (vs 2% in 2023).

Figure 35. Percentage distribution of SAE classified as ‘human error’ by type of error in 2024

Table 27. Summary of total number of SAE classified as ‘human error’ by type of error; 2023 vs. 2024

The percentage distribution of SAE by specification for each reporting country is displayed in Figure

36.

Haemovigilance Annual Report 2025 52

Figure 36. Percentage distribution of SAE by specification per country in 2024

Note: countries reporting zero SAE cases (BG, IS and LT) are not shown above.

3.6.1 Qualitative Thematic Analysis

Using the data presented in Annex 5. Additional information on SAE by specification, a qualitative

thematic analysis was carried out.

Theme 1: Under-Documentation

This is the single most important theme. The majority of SAE in the two of the largest specification categories (component defect and equipment failure) are analytically invisible as "no additional information provided" or "N/A" represents the largest entry by case count:

• Component defect: 2 626 + 15= 2 641 of 2 848 cases (93%) • Equipment failure: 423 +12= 435 of 510 cases (85%)

Theme 2: Patient Identification and Wrong-Patient Events

Across human error and system failure categories, wrong-patient and ICBT events emerge as a

persistent multi-level failure mode, appearing in several entries:

Key countries shaping process safety picture ➢ Comment RO: “In 2023, there were limitations in our reporting system that led to underreporting or incomplete

documentation of events. For this reason, “N/A” was indicated for that year. Starting in 2024, we implemented a

revised SAE reporting protocol, along with additional training sessions for personnel involved in the identification

and reporting of adverse events. The reporting criteria have been broadened to include cases previously

considered minor or ambiguous, in alignment with updated haemovigilance recommendations.”

➢ Excluding Romania's contribution, the distribution of SAE by specification in 2024 would revert to a pattern

closely aligned with 2023: human error would remain the predominant root cause (38%), followed by ‘other’

(18%), system failure (15%) and component defect (14%).

Haemovigilance Annual Report 2025 53

• 67 cases of wrong patient transfused under human error — described as a combination of identity failures across prescribing, laboratory communication, HBB checking and bedside verification

• 11 cases of transfusion/issue of incorrectly labelled component • 9 cases of ICBT due to insufficient or no bedside check • 9 cases of ICBT due to incorrect product allocation during issue • 8 cases of WBIT, labelling error, donor mix-up

• 14 cases of wrong patient transfused under system failure — same multi-layered failure description

Theme 3: Donor Disclosure Integrity

A cluster of entries across component defect, human error, other and system failure categories all point to an underlying vulnerability: the blood safety system depends heavily on donors providing complete and accurate health information and this dependency is frequently not met.

Relevant entries include:

• 58 cases (component defect): PDI known at time of donation but not disclosed by donor, or information that led to later refusal may have affected prior donations, including newly diagnosed malignancy and Borrelia infection

• 50 cases (other): Donor did not provide correct or full information at donation • 30 cases (human error): Unreported recent travel to malaria‑ or Chagas‑endemic areas,

largely due to donor omission and insufficient emphasis during the pre‑donation interview • 26 cases (human error): Donor accepted despite information available for exclusion;

insufficient donor deferral • 33 cases (system failure): Donor eligibility violations • 3 cases (other): Patient hid therapy/diagnosis information; BCs distributed for use • 3 cases (human error): Donor had too poor language skills to adequately understand consent

forms • 1 case (system failure): Different procedure for accepting donor regarding medical

declaration form

Taken together, these entries describe a spectrum of failures ranging from deliberate concealment by the donor, to language and literacy barriers preventing informed participation in the screening process, to inconsistencies in how medical declaration forms are administered. These cases are not donor failures alone; they reflect a screening environment that does not create adequate conditions for honest self-disclosure, whether due to time pressure, lack of private interview space, language barriers or social expectations.

Theme 4: IT and Software Failures

IT-related failures appear across multiple specification categories, often without adequate description and some likely misclassified. However, the entries that do contain detail are quite educational:

• 2 cases (system failure): Typing errors when entering positive infection parameters were interpreted as negative by the electronic data processing (EDP) system due to poor programming

• 3 cases (component defect): Insufficient deferral period after risk of infection due to incorrect programming in EDP

• 36 cases (system failure): IT system and transport failures, flagged as subject to systematic maintenance checks and procedure reminders (suggesting known, recurring issues)

• 2 cases (equipment failure): IT-software error and machine malfunction

Haemovigilance Annual Report 2025 54

• 1 case (equipment failure): Incorrect D weak declaration as D negative due to EDP misprogramming

• 1 case (equipment failure): Omission of alloantibody screening test of donors due to EDP misprogramming

• 1 case (system failure): Failure to provide irradiated units after introduction of a new lab system

• 1 case (materials): Units pathogenically reduced but exposure report had incorrect date due to a system date change

The EDP programming error that caused positive infection results is a finding of particular concern as the staff member entered the data correctly, but a software validation failure inverted a safety- critical result. This type of hidden system failure is particularly dangerous because it can affect multiple samples before detection and may not be identified through routine individual case review.

Theme 5: Component Integrity Classification

The materials category is dominated by burst blood bags and plasma chylostasis (combined: 112

of 135 cases, 83%) and several entries in other categories describe similar failures:

• 49 cases: Burst blood bag • 33 cases: Burst blood bag with plasma chylostasis • 30 cases: Plasma chylostasis (alone) • 7 cases (other): Leaking packs, clots in unit, minor sediment, haemolysed units • 11 cases (equipment failure): Burst blood bag

Chylostasis (lipaemic plasma) is not a manufacturing defect in the conventional sense; it reflects

donor metabolic status at the time of donation (typically high triglyceride levels due to recent fatty

meal) and is a known quality issue in plasma components. Its frequency in the materials category

alongside burst bags suggests possible misclassification.

The classification boundary between component defect, materials and equipment failure requires

clarification in the Common Approach guidance, particularly for burst bag events and component

appearance deviations.

Theme 6: Emerging and Environmental Risks

• 2 cases: National epidemiological situation increased HEV cases linked to sausage consumption; additional testing initiated; positive cases found on archive samples that had already been transfused

• 3 cases: Extensive floods (presumably affecting storage, distribution or establishment operations)

• 24 cases: Covid and Herpes Zoster in donor selection

The HEV cluster is particularly instructive. It describes a food-borne outbreak that translated into a

blood safety risk because HEV-viraemic donors donated during the incubation period before the

epidemiological signal was identified and additional testing was introduced. The retrospective

identification of positive cases in already-transfused archive samples indicates that recipient

lookback was initiated, a positive finding in terms of haemovigilance response, but the case

illustrates the inherent lag between a community infection event and a blood safety system

response. This is the type of emerging risk scenario that national haemovigilance systems are

structurally poorly equipped to detect prospectively and it underscores the importance of blood

safety authorities maintaining active surveillance links with national infectious disease and public

health agencies.

Haemovigilance Annual Report 2025 55

The flood events, while small in number, represent a type of risk (infrastructure and environmental

disruption) that is largely absent from standard SAE reporting frameworks but likely to grow in

relevance as climate-related events increase in frequency across Europe.

Theme 7: Thin Evidence of CAPA

Across all specification categories, explicit reference to CAPA is rare. Where CAPA language does

appear, it takes the following forms:

• "Subject to systematic equipment maintenance checks and systematic reminders of the procedures" (equipment failure, system failure)

• "A systematic reminder is carried out for staff who have not respected PDI procedures" (human error)

• "Additional blood donation testing was started" following HEV cluster (other)

The most implicit CAPA signals come from the multi-layered wrong-patient event descriptions, which acknowledge systemic process complexity, but even here, no corrective actions are described and the narrative stops at failure description rather than resolution.

Haemovigilance Annual Report 2025 56

4 Severe Adverse Reactions in Donors (Voluntary)

An adverse donor reaction is described as unintended response in a donor associated with the

collection of blood/BC which can happen acutely during the donation process or delayed after the

donor has left the donation site.

According to Directive 2005/61/EC, SAR in donors are not reportable unless they impact the quality

and safety of the BC. In the interest of transparency in donor vigilance and to facilitate international

comparison, the EC encourages MS to submit these reactions on a voluntary basis.

Reactions in donors are reportable only if they were serious in nature.

The Common Approach, 2025 edition [1], states that “SAR in donors should be reported if they were

likely/probably or certainly caused by the donation (IL 2 or 3). Concerning reports where SAR in

donors are confirmed to be fatal, all cases should be reported where a fatality was possibly, probably

or certainly related to the donation (i.e. IL 1, 2 or 3).”

4.1 Geographic distribution

Twenty-three countries (AT, BE, BG, CY, CZ, DK, EE, FI, FR, DE, EL, IS, IE, IT, LU, NL, NO, PL, PT, RO, SK,

SI and SE) reported on a voluntary basis, a total of 2 260 SAR in donors in 2024. This was a 36%

decrease in comparison with 2023 (3 530 SAR).

As shown in Figure 37, there was a wide range of SAR incidence rates in WB donors, with the lowest

being 0 (AT, HR, LV and ES) and the highest reaching 122 (NO).

Key findings

➢ 2 260 SAR in donors were reported (36% drop vs 2023).

➢ Vasovagal reactions dominate (77% in WB, 54% in apheresis).

➢ France’s scope update (only grades 3–4 reported) significantly reduced overall donor SAR frequency.

➢ For the first time, 4 fatalities were reported in donors (1 in WB and 3 in apheresis).

Haemovigilance Annual Report 2025 57

Figure 37. SAR incidence rates in WB donors per 100 000 WB collections in Europe in 2024

Note: LT and SK reported N/A for the number of WB collections, so they appear above in dark grey; UK(NI) reported N/A for

the number of SAR, also shown above in dark grey.

Similarly, there was a wide range of SAR incidence rates in apheresis donors (Figure 38), with the

lowest being 0 (BG, HR, CY, FI, EL, IS, IE, LV, PT and RO) and the highest reaching 171 (NO).

Figure 38. SAR incidence rates in apheresis donors per 100 000 apheresis collections in Europe in 2024

Note: LT and SK reported N/A for the number of apheresis collections, so they appear above in dark grey; SE and UK(NI)

reported N/A for the number of SAR, also shown above in dark grey.

Haemovigilance Annual Report 2025 58

4.2 Country-specific trends (2023 vs. 2024)

Figure 39 compares the SAR incidence rates in WB donors (per 100 000 WB collections) per country

in 2024 with 2023.

Figure 39. SAR incidence rates in WB donors per 100 000 WB collections per country; 2023 vs. 2024

Note 1: for FR, rates are not comparable due to change in the reporting scope (only grade 3 (severe) and grade 4 (death)

reported in 2024 vs all grades in 2023).

Note 2: LT reported N/A for the number of WB collections in both 2023 and 2024. In 2023, RO reported SAR cases but N/A

for the number of WB collections. In 2024, SK reported SAR cases but N/A for the number of WB collections. UK(NI)

reported N/A for the number of SAR in both 2023 and 2024.

As shown in Figure 39, BE and EE had significant increases in the SAR incidence rate in comparison

with 2023, while FR had a large drop explained by a change in the national reporting scope, which

restricted submitted donor SAR to grade 3 (severe) and grade 4 (fatal) reactions only, in contrast to

all grades reported in prior years. This methodological change substantially reduces the

comparability of French donor SAR data between 2023 and 2024, and caution should be exercised

when interpreting France's apparent improvement.

The comparison of SAR incidence rates in apheresis donors (per 100 000 apheresis collections)

between 2024 and 2023 is presented in Figure 40.

Haemovigilance Annual Report 2025 59

Figure 40. SAR incidence rates in apheresis donors per 100 000 apheresis collections per country; 2023 vs.

2024

Note 1: for FR, rates are not comparable due to change in the reporting scope (only grade 3 (severe) and grade 4 (death)

reported in 2024 vs all grades in 2023).

Note 2: LT reported N/A for the number of apheresis collections in both 2023 and 2024. In 2024, SK reported SAR cases but

N/A for the number of apheresis collections. SE reported N/A for both the number of SAR and the number of apheresis

collections in both 2023 and 2024. UK(NI) reported N/A for the number of SAR in both 2023 and 2024.

Key countries shaping the donor safety picture ➢ Comment FR: “from the 2nd of January 2024, the reporting of SAR donors focus on the most serious adverse

reactions: only grades 3 (severe) and 4 (death) needs to be reported to the NCA (grades 1 and 2 are notified, traced

and analysed at local level of BE). This allows also the harmonization of French data with European and international

modalities, for greater comparability of data between countries, particularly EU MS.”

Haemovigilance Annual Report 2025 60

4.2.1 Overview of SAR in donors by type of donor per country

The distribution of number of SAR by type of donor per reporting country is shown in Figure 41.

Figure 41.Number of SAR in donors by type of donor per country in 2024

Note: UK(NI) reported data N/A.

4.3 Overview of SAR in donors by type of reaction

SAR in donors are classified as per table below.

Table 28. Classification of donor reactions

Type of Reaction

Vasovagal reaction

Citrate reaction (specific to apheresis)

Allergic reaction

Nerve injury/irritation

Haematoma NEW!

Major cardio-or cerebrovascular event (CCVE) up to 24 hours after donation

Other

General (only if data for the reactions listed above are not available)

Note 1: haematoma is reserved for donors in whom haematoma was present without (serious) nerve injury/irritation

Note 2: for major CCVE an imputability assessment should be made.

Haemovigilance Annual Report 2025 61

4.3.1 SAR in WB donors

Twenty-three countries (BE, BG, CY, CZ, DK, EE, FI, FR, DE, EL, IS, IE, IT, LU, NL, NO, PL, PT, RO, SK, SI,

ES and SE) reported a total of 1 865 SAR in donors in relation to WB collections (15 679 193). This

represents a 28% decrease in comparison with the previous year when 2 573 SAR were recorded by

21 countries.

As presented in Figure 42, in 2024, vasovagal reactions accounted for the majority of donor reactions

(77%), followed by nerve injury/irritation (12%) and other (6%). This is a similar distribution to the

one observed in 2023.

Vasovagal reaction is known to be the most common SAR that happened to donors during or after

the blood donation process has completed. Donors may experience either acute or delayed feeling

of dizziness usually associated with nausea, sweating and general discomfort; and maybe

associated with bradycardia and hypotensive episodes.

For more details related to ‘other’ and major CCVE, refer toAnnex 6. Additional information on SAR

in donors per reporting country.

Figure 42. Percentage distribution of SAR in WB donors by type of reaction in 2024

Note: zero SAR cases reported for allergic reactions.

Table 29. Summary of total number of SAR in WB donors by type of reaction; 2023 vs. 2024

Haemovigilance Annual Report 2025 62

The number of donor reactions by type for each reporting country is presented comparatively for

2023 and 2024 in Table 30.

Table 30. SAR in WB donors by type of reaction per country; 2023 vs. 2024

Note 1: * for FR, data between years is not comparable due to change in the reporting scope (only grade 3 (severe) and grade

4 (death) reported in 2024).

Note 2: LV and LT reported zero SAR both in 2023 and 2024 (not shown above); UK(NI) reported data N/A both in 2023 and

2024 (not shown above).

Note 3: zero SAR cases reported for allergic reactions in both 2023 and 2024.

In comparison with the previous year, the total number of vasovagal reactions in WB donors

decreased substantially (Table 29). This is primarily due to France's revised reporting scope (only

grade 3 and 4 events reported in 2024, versus all grades in 2023).

The percentage distribution of SAR in WB donors by type of reaction for each reporting country is

displayed in Figure 43.

Figure 43. Percentage distribution of SAR in WB donors by type of reaction per country in 2024

Note 1: AT, HR, LV and LT reported zero SAR (not shown above); UK(NI) reported data N/A (not shown above).

Note 2: zero SAR cases reported for allergic reactions.

Haemovigilance Annual Report 2025 63

4.3.2 SAR in apheresis donors

Fifteen countries (AT, BE, CZ, DK, EE, FR, DE, IT, LU, NL, NO, PL, SK, SI and ES) reported a total of 395

SAR in donors following apheresis collections (7 590 344). This was a 59% reduction in comparison

with the previous year when 957 SAR were reported by 12 countries.

The distribution of apheresis donor reactions in 2024 is shown in Figure 44.

For more details related to ‘other’ and major CCVE, refer toAnnex 6. Additional information on SAR

in donors per reporting country.

Figure 44. Percentage distribution of SAR in apheresis donors by type of reaction in 2024

Table 31. Summary of total number of SAR in apheresis donors by type of reaction; 2023 vs. 2024

The number of donor reactions by type for each reporting country is presented comparatively for

2023 and 2024 in Table 32.

Haemovigilance Annual Report 2025 64

Table 32. SAR in apheresis donors by type of reaction per country; 2023 vs. 2024

Note 1: BG, HR, CY, FI, EL, IS, LV, LT, PT and RO reported zero SAR in both 2023 and 2024 (not shown above); UK(NI) reported

data N/A in both 2023 and 2024 (not shown above).

Note 2: * for FR, data between years is not comparable due to change in the reporting scope (only grade 3 (severe) and

grade 4 (death) reported in 2024)

In comparison with the previous year, the total number of vasovagal reactions in apheresis donors

decreased substantially in 2024 (Table 31). As noted in Table 32, this change is not directly

comparable with 2023 data due to France's revised reporting scope, as mentioned before. In 2023,

French vasovagal reactions accounted for 84% of the European total for apheresis donors; their

effective removal from the 2024 total accounts for the majority of the observed reduction.

The percentage distribution of SAR in apheresis donors by type of reaction for each reporting country

is displayed in Figure 45.

Haemovigilance Annual Report 2025 65

Figure 45. Percentage distribution of SAR in apheresis donors by type of reaction per country in 2024

Note: BG, HR, CY, FI, EL, IS, IE, LV, LT, PT and RO reported zero SAR (not shown above); SE and UK(NI) reported data N/A (not

shown above).

4.4 Fatalities in donors

In 2024, four fatalities (1 in WB and 3 in apheresis) were reported in donors. This is a significant

finding given that no donor fatalities were reported in previous years. The four cases have been

presented alongside some points for consideration at the Vigilance & Traceability Working Group

annual meeting (27th–28th April 2026).

Haemovigilance Annual Report 2025 66

CONCLUSIONS

Haemovigilance, the systematic surveillance of transfusion-related adverse reactions and events, is

fundamental to the continuous improvement of blood safety across Europe. The 2025 SARE Report,

drawing on data submitted by 28 countries for the 2024 reporting period, provides the most

comprehensive picture of European transfusion safety to date.

The findings presented below should be interpreted in the context of the methodological limitations

outlined in this report, in particular the variability in reporting completeness, the evolving

composition of the contributing country set and the structural impact of Romania's dataset on

aggregate metrics.

A. Summary of Key Findings

1. Activity Data

• The WB donation rate (median) declined 8% while the apheresis’ remained stable.

• Transfusion activity across Europe remained broadly stable in 2024. Approximately 16.5

million units of blood/BC were transfused across reporting countries, with the median per-

country transfusion rate (38.6 per 1 000 population) consistent with 2023.

• RBC continue to represent the dominant component type by volume, though a 13% increase

in plasma units issued relative to 2023 is of note.

• The total number of recipients transfused increased across all types of BC, reflecting

sustained clinical demand.

2. SAR (IL 2-3)

• The total number of SAR (IL 2-3) in recipients was 1 360 in 2024, representing a decrease of

approximately 9% compared to the previous year. The total SAR (IL 2-3) incidence remains

consistently low and fairly stable. Platelets consistently show the highest median SAR (IL 2

3) incidence, followed by RBC and plasma.

• FNHTR, anaphylaxis/hypersensitivity and TACO accounted for the three most prevalent

reaction categories, a distribution that has remained consistent since 2022 and is aligned

with data from established haemovigilance systems including SHOT.

• The most clinically significant finding of the 2024 reporting cycle is the reduction in recipient

fatalities (IL 2-3) to 11, the lowest annual figure in the 2021–2024 period and ten fewer than

in 2023. Over this period, immunological haemolysis (32 deaths), TACO (18 deaths) and

TRALI (15 deaths) remain the three leading cumulative causes of transfusion-related

mortality. This is a pattern consistent with fatality profiles reported by the FDA and the

International Haemovigilance Network (IHN), reinforcing that these reaction types represent

the primary preventable mortality burden in high-income transfusion systems globally.

• Fourteen TTIs (IL 2-3) were reported in 2024, six fewer than in 2023, with bacterial infections

predominantly associated with platelet components, which is consistent with international

surveillance data on platelet contamination risk. The proportion of TTBI cases with pathogen-

level identification improved substantially, from 47% in 2023 to 83% in 2024, representing a

meaningful quality improvement in post-investigation reporting.

Haemovigilance Annual Report 2025 67

3. SAE

• The total number of SAE increased dramatically (108%), translating into a total SAE incidence

of 19.5 per 100 000 units processed (vs 9.7 in 2023), driven primarily by Romania’s reporting

update approach. However, at the median country level, SAE patterns remained fairly stable.

When Romania's contribution is excluded, the total incidence falls to 6.4, comparable with

previous years.

• Procedurally, Romania's dataset, which alone accounts for 67% of all reported events, altered

the specification distribution (component defect rising from 16% to 60% of all SAE).

Excluding Romania’s contribution, human error continued to feature as the leading cause

(38% vs 42% in 2023).

• Analysis of SAE narrative data across all specification categories reveals that the majority of

reported events, particularly within component defect (93%) and equipment failure (85%),

were submitted without any accompanying detail, making them as analytically invisible.

Where narrative data were available, wrong-patient and ICBT events consistently emerged as

multi-layer system failures (covering prescribing, laboratory communication and bedside

verification) while a recurring cluster of donor disclosure failures, ranging from deliberate

non-disclosure to language and literacy barriers exposed a structural over-reliance on donor

self-reporting as the primary safety screen.

4. SAR in Donors (Voluntary)

• A 36% reduction in donor SAR was observed (primarily driven by France’s scope update). The

most frequently reported type of SAR were vasovagal reactions. France historically

contributed the majority of vasovagal reactions reported in WB and apheresis donors; its

exclusion of grades 1 and 2 cases in 2024 lowers the European aggregate while concealing

true comparability with prior years for this parameter.

• Four donor fatalities were reported for the first time in 2024.

B. Major Challenges and Points for Consideration

• A persistent gap in European haemovigilance is the lack of complete denominator data which

limits incidence comparability.

• Despite widespread awareness and clear mitigation guidelines, TACO remains stubbornly

persistent as one of the leading causes of transfusion-related mortality. Point for

consideration: An example of best practice is the SHOT pre-transfusion TACO risk

assessment [3]. Therefore, compliance with TACO prevention protocols could ideally be

incorporated as an audit metric within national haemovigilance programmes.

• Fatality narratives remain a critical source of learning. While general compliance with

Common Approach is evident, harmonisation of detail remains necessary. Point for

consideration: Case narratives, when shared, are far more valuable when they include

enough contextual detail to support a preventability judgement. Elements that tend to make

this possible include whether pre-transfusion risk assessment was performed, whether

known mitigations or patient-specific protocols were available and applied, and what

possible contributory factors were identified. SHOT [2] illustrates this approach well, with a

dedicated chapter on deaths and per-category fatality narratives that cover human-factor and

contributory factor analysis.

Haemovigilance Annual Report 2025 68

• Point for consideration: Minimum documentation standards for SAE submissions should be

strengthened. A case reported without any accompanying narrative or root cause

information should not be considered a complete submission.

• A SAE finding of particular concern is a documented software programming error in which

positive infectious disease parameters were interpreted as negative by the data entry system

due to poor programming logic. This is a latent system failure with the potential to affect

multiple donations before detection. Point for consideration: Competent authorities should

enquire whether a formal software incident report was filed with the relevant medical device

regulatory authority in addition to the haemovigilance reporting. IT system changes,

including software updates, new laboratory information system implementations and

interface changes should be subject to mandatory prospective validation protocols before

go-live.

The 2024 data demonstrate meaningful progress across several aspects of transfusion safety,

including a record low number of recipient fatalities and reductions in both TTIs and SAR. However,

persistent gaps in the completeness of SAE reporting, the ongoing preventable burden of TACO and

immunological haemolysis, and the concerns highlighted by donor fatality data underscore the need

for sustained and coordinated action. Strengthened efforts in staff training, as well as the

harmonisation of practices and reporting standards across (inter)national haemovigilance systems

remain essential.

Haemovigilance Annual Report 2025 69

List of Abbreviations AE Adverse Event AT Austria ALI Acute Lung Injury BE Belgium AML Acute Myeloid Leukaemia BG Bulgaria AHTR Acute Haemolytic Transfusion Reaction HR Croatia BC Blood Component CY Cyprus BE Blood Establishment CZ Czechia BNP B-Type Natriuretic Peptide Levels DK Denmark CAPA Corrective and Preventive Actions EE Estonia CCVE Cardio-or Cerebrovascular Event FI Finland CMV Cytomegalovirus FR France EC European Commission DE Germany ECDC European Centre for Disease Prevention and Control EL Greece EDQM European Directorate for the Quality of Medicines & HealthCare HU Hungary EDP Electronic Data Processing IS Iceland EU European Union IE Ireland DHTR Delayed Haemolytic Transfusion Reaction IT Italy FDA Food and Drug Administration LV Latvia FNHTR Febrile Non-Haemolytic Transfusion Reaction LI Liechtenstein HBB Hospital Blood Bank LT Lithuania HBV Hepatitis B Virus LU Luxembourg HCV Hepatitis C Virus MT Malta HEV Hepatitis E Virus NL Netherlands HPA Human Platelet Antigen NO Norway IBCT Incorrect Blood Component Transfused PL Poland IHN International Haemovigilance Network PT Portugal IL Imputability Level RO Romania ISBT International Society of Blood Transfusion SK Slovakia MTOC More Than One Blood Component SI Slovenia MS Member States ES Spain N/A Not Available SE Sweden NCA National Competent Authorities UK United Kingdom PDI Post-Donation Information UK(NI) Northern Ireland PMP Per One Million Population PTP Post-Transfusion Purpura RBC Red Blood Cells RCC Red Cell Concentrates SAE Serious Adverse Events SAR Serious Adverse Reactions SARE Serious Adverse Reactions and Events SOP Standard Operating Procedure SHOT UK’s Serious Hazards of Transfusion TACO Transfusion-Associated Circulatory Overload TAD Transfusion-Associated Dyspnoea

TRALI Transfusion-Related Acute Lung Injury

TTBI Transfusion-Transmitted Bacterial Infection

TTFI Transfusion-Transmitted Fungal Infection

TTI Transfusion-Transmitted Infection

TTPRI Transfusion-Transmitted Prion Infection

TTPI Transfusion-Transmitted Parasitical Infection

TTVI Transfusion-Transmitted Viral Infection

VES Vigilance Expert Subgroup

WB Whole Blood

WBIT Wrong Blood in Tube

WHO Word Health Organization

Haemovigilance Annual Report 2025 70

List of Figures Figure 1. Yearly trendinwhole blood donation rate (median per-country) per 1 000 population; 2021–2024 10 Figure 2. Yearly trend in apheresis donation rate (median per-country) per 1 000 population; 2021–2024 ... 11 Figure 3. Yearly trends in blood/BC issuance, processing and transfusion rates (median per-country) per 1

000 population; 2021–2024 ................................................................................................................................... 11 Figure 4. Yearly trend in RBC transfusion rate (median per-country) pmp; 2021–2024 ................................... 12 Figure 5. Yearly trends in platelet and plasma transfusion rates (median per-country) pmp; 2021–2024 ...... 12 Figure 6. Yearly trend inWB transfusion rate (median per-country) pmp; 2021–2024 ..................................... 13 Figure 7. Yearly trend in recipient rate regardless of type of BC (median per-country) per 1 000 population;

2021–2024 .............................................................................................................................................................. 14 Figure 8. WB collection rates in Europe per 1 000 population in 2024 ............................................................... 15 Figure 9. Apheresis collection rates in Europe per 1 000 population in 2024 .................................................... 15 Figure 10. Blood/BC issuance rates in Europe per 1 000 population in 2024 .................................................... 16 Figure 11. Blood/BC transfusion rates in Europe per 1 000 population in 2024................................................ 17 Figure 12. Recipient rates (regardless of the type of BC) in Europe per 1 000 population in 2024 .................. 18 Figure 13. RBC transfusion rates pmp per country; 2023 vs. 2024 .................................................................... 20 Figure 14. Platelet transfusion rates pmp per country; 2023 vs. 2024 ............................................................... 20 Figure 15. Plasma transfusion rates pmp per country; 2023 vs. 2024 ............................................................... 21 Figure 16. WB transfusion rates pmp per country; 2023 vs. 2024 ...................................................................... 21 Figure 17. Yearly trends in SAR (IL 2-3) incidence: total SAR (IL 2-3) incidence/100 000 units transfused and

median per-country SAR (IL 2-3) incidence/100 000 units transfused; 2021–2024 .......................................... 23 Figure 18. SAR (IL 2-3) incidence rates per 100 000 units transfused in Europe in 2024 ................................. 24 Figure 19. Yearly trendsin SAR (IL 2-3) incidence (median per-country) per 100 000 units transfused of

platelets, plasma and RBC; 2021–2024 ................................................................................................................ 25 Figure 20. Summary of total number of fatalities (IL 2-3) by type of BC; 2021–2024 ....................................... 26 Figure 21. Number of SAR (IL 2-3) by type of BC per country in 2024 ................................................................ 28 Figure 22. Yearly trends in percentage of total SAR (IL 2-3) by the main reaction types; 2021–2024 ............. 30 Figure 23. Distribution of SAR (IL 2-3) classified as ‘other’ in 2024 ................................................................... 32 Figure 24. Yearly trends in SAE incidence: total SAE incidence/100 000 units processed and median per-

country SAE incidence/100 000 units processed; 2021–2024 ........................................................................... 41 Figure 25. SAE incidence rates per 100 000 units processed in Europe in 2024 ............................................... 42 Figure 26. SAE incidence rates per 100 000 units processed per country; 2023 vs. 2024 ............................... 42 Figure 27. Number of SAE per country in 2024 .................................................................................................... 43 Figure 28. Percentage distribution of SAE by activity step in 2024 .................................................................... 45 Figure 29. Distribution of SAE classified with the activity step ‘other’ in 2024 .................................................. 46 Figure 30. Percentage distribution (and absolute numbers) of SAE classified as ‘other’ vs the nine defined

activity steps per reporting country in 2024 ......................................................................................................... 47 Figure 31. Yearly trends in percentage of total SAE by specification; 2021–2024 ............................................ 48 Figure 32. Percentage distribution of SAE by specification in 2024 ................................................................... 49 Figure 33. Distribution of SAE for the defined activity steps by specification in 2024 ...................................... 50 Figure 34. Distribution of SAE assigned to ‘other’ activity step entries by specification in 2024 ..................... 51 Figure 35. Percentage distribution of SAE classified as ‘human error’ by type of error in 2024 ....................... 51 Figure 36. Percentage distribution of SAE by specification per country in 2024 ............................................... 52 Figure 37. SAR incidence rates in WB donors per 100 000 WB collections in Europe in 2024 ......................... 57 Figure 38. SAR incidence rates in apheresis donors per 100 000 apheresis collections in Europe in 2024.... 57 Figure 39. SAR incidence rates in WB donors per 100 000 WB collections per country; 2023 vs. 2024 .......... 58 Figure 40. SAR incidence rates in apheresis donors per 100 000 apheresis collections per country; 2023 vs.

2024 ......................................................................................................................................................................... 59 Figure 41. Number of SAR in donors by type of donor per country in 2024 ....................................................... 60 Figure 42. Percentage distribution of SAR in WB donors by type of reaction in 2024 ...................................... 61 Figure 43. Percentage distribution of SAR in WB donors by type of reaction per country in 2024................... 62 Figure 44. Percentage distribution of SAR in apheresis donors by type of reaction in 2024 ............................ 63

Haemovigilance Annual Report 2025 71

Figure 45. Percentage distribution of SAR in apheresis donors by type of reaction per country in 2024 ........ 65

List of Tables Table 1. Summary of transfusion rates (median per-country) pmp by type of BC; 2023 vs. 2024 ................... 13 Table 2. Summary of total number of units issued and transfused by type of BC; 2023 vs. 2024 ................... 19 Table 3. Summary of total number of recipients transfused by type of BC; 2023 vs. 2024 .............................. 19 Table 4. Definition of imputability levels ............................................................................................................... 22 Table 5. SAR (IL 2-3) incidence rates/100 000 units (RBC, platelets or plasma) transfused per country; 2023

vs. 2024 ................................................................................................................................................................... 26 Table 6. Number ofSAR (IL 2-3) per country reporting missing denominator data in RBC, platelets and

plasma; 2023 vs. 2024 ........................................................................................................................................... 27 Table 7. Summary of total number of SAR (IL 2-3) and fatalities (IL 2-3) by type of BC; 2023 vs. 2024 .......... 27 Table 8. Summary of total number of fatalities (IL 2-3) by type of BC per reporting country in 2024 .............. 28 Table 9. Types of reportable transfusion reactions ............................................................................................. 29 Table 10. Percentages of total SAR (IL 2-3) by the main reaction types; 2021–2024 ....................................... 29 Table 11. Summary of total number of fatalities (IL 2-3) by type of reaction; 2021–2024 ............................... 31 Table 12. Summary of total number of SAR (IL 2-3) by type of reaction; 2023 vs. 2024 .................................. 31 Table 13. Summary of number of SAR (IL 2-3) (excluding fatalities) by the top 5 reaction types in WB, RBC

and platelets; 2023 vs. 2024 .................................................................................................................................. 32 Table 14. Summary of SAR (IL 2-3) (excluding fatalities) by the top 5 reaction types in plasma and MTOC;

2023 vs. 2024 ......................................................................................................................................................... 33 Table 15. Summary of TTIs (IL 2-3) by type of TTI; 2023 vs. 2024 ..................................................................... 33 Table 16. Summary of TTIs (IL 2-3) by type of TTI and by type of BC; 2023 vs. 2024 ....................................... 34 Table 17. Summary of the infectious pathogen reported in TTBIs by type of BC per country in 2024 ............ 34 Table 18. Summary of the infectious pathogen reported in TTVIs by type of BC per country in 2024 ............ 34 Table 19. Summary of number of fatalities by type of reaction and by IL 2 or 3 in 2024 .................................. 35 Table 20. Summary of number of fatalities (IL 2-3) by type of reaction and by type of BC; 2023 vs. 2024 ..... 35 Table 21. Criteria for inclusion of SAE .................................................................................................................. 39 Table 22. Definitions of activity steps for SAE ..................................................................................................... 44 Table 23. Summary of total number of SAE by activity step; 2023 vs. 2024 ..................................................... 46 Table 24. Percentage of SAE classified with activity step ‘other’ per reporting country; 2023 vs. 2024 .......... 47 Table 25. Definitions of specifications (causes) for SAE .................................................................................... 48 Table 26. Summary of total number of SAE by specification; 2023 vs. 2024 .................................................... 50 Table 27. Summary of total number of SAE classified as ‘human error’ by type of error; 2023 vs. 2024 ........ 51 Table 28. Classification of donor reactions ......................................................................................................... 60 Table 29. Summary of total number of SAR in WB donors by type of reaction; 2023 vs. 2024 ........................ 61 Table 30. SAR in WB donors by type of reaction per country; 2023 vs. 2024 .................................................... 62 Table 31. Summary of total number of SAR in apheresis donors by type of reaction; 2023 vs. 2024 ............. 63 Table 32. SAR in apheresis donors by type of reaction per country; 2023 vs. 2024 .......................................... 64

List of Annexes

Annex 1. Executive summary (2021–2024) ............................................................................................... 73 Annex 2. Reporting establishments per capita (pmp) ............................................................................... 74 Annex 3. Completeness dashboard per metric per country in 2024 ........................................................ 75 Annex 4. Definitions of the reportable types of transfusable reactions .................................................. 76 Annex 5. Additional information on SAE by specification ........................................................................ 78 Annex 6. Additional information on SAR in donors per reporting country ............................................... 81 Annex 7. SAR IL 1 (Voluntary) ..................................................................................................................... 83

Haemovigilance Annual Report 2025 72

Annex 8. Data Supplement – Donation rates of WB and apheresis per 1 000 population in the last four years

.............................................................................................................................................................. 86 Annex 9. Data Supplement – Issuance, transfusion and processing rates per 1 000 population in the last four

years ..................................................................................................................................................... 88 Annex 11. Data Supplement – Transfusion rates pmp by type of BC (except MTOC) in the last four years 89 Annex 12. Data Supplement - SAR (IL 2-3) and SAE incidence rates in the last four years .................... 90 Annex 13. Data Supplement - SAR (IL 2-3) incidence rates/100 000 units transfused for each type of BC

(excluding MTOC) in the last four years ............................................................................................ 91 Annex 14. References ................................................................................................................................. 92

Haemovigilance Annual Report 2025 73

Annex 1. Executive summary (2021–2024)

Note 1:the observed SAE increase in 2024 is primarily due to Romania’s data

Note 2: *recipients transfused was obtained with the sum of number of recipients for each type of BC (i.e. WB, RBC, platelets and plasma) from countries which reported per type of

BC plus the number of recipients from countries which only reported the overall number (i.e. regardless of type of BC). In 2024, it results from 19 countries (2 866 369) plus the

number of recipients from EE and EL (132 307) which only reported the overall number.

Note 3: for details on how total incidence was calculated refer to section ‘Key indicators definitions’ in Methodology. This disclosure allows for a better understanding of the

potential limitations or biases in the incidence calculation.

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Annex 2. Reporting establishments per capita (pmp)

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Annex 3. Completeness dashboard per metric per country in 2024

Note 1: HU, MT and LI did not report in 2024.

Note 2: N/A- data not available; Yes(0)- country reported 0 units.

Haemovigilance Annual Report 2025 76

Annex 4. Definitions of the reportable types of transfusable reactions

Term Definition

Transfusion-related acute

lung injury (TRALI)

In patients with no evidence of acute lung injury (ALI) prior to transfusion, TRALI is diagnosed if a new ALI is present: • Acute onset

• Hypoxemia

- PaO2/FiO2 < 300 mm Hg or

- Oxygen saturation is < 90% on room air or

- Other clinical evidence • Bilateral infiltrates on frontal chest radiograph • No evidence of left atrial hypertension (i.e. circulatory overload) • No temporal relationship to an alternative risk factor for ALI during or within 6 hours of completion of transfusion. Neither presence of anti-HLA or anti-HNA antibodies in donor(s) nor confirmation of

cognate antigens in recipient is required for diagnosis.

Anaphylaxis/hypersensitivity

There is anaphylaxis when, in addition to mucocutaneous systems there is airway compromise or severe hypotension requiring vasopressor treatment (or associated symptoms like hypotonia, syncope). The respiratory signs and symptoms may be laryngeal (tightness in the throat, dysphagia, dysphonia, hoarseness, stridor) or pulmonary (dyspnoea, cough, wheezing/bronchospasm, hypoxemia). Such a reaction usually occurs occurring during or very shortly after transfusion.

Febrile non-haemolytic

transfusion reaction

(FNHTR)

Only the most serious cases of FNHTR should be accounted for:

Fever (≥39ºC oral or equivalent AND a change of ≥2ºC from pre-transfusion value) and/or

chills/rigors.

Immunological haemolysis

• due to ABO incompatibility: acute haemolytic transfusion reaction (AHTR) caused by

transfusion of ABO‑incompatible RBCs, mediated by naturally occurring antibodies.

• due to other alloantibody: haemolytic transfusion reaction caused by recipient

alloantibodies to non‑ABO antigens (e.g., Rh, Kidd, Kell), presenting as an acute or delayed

haemolytic transfusion reaction.

Post-transfusion purpura

(PTP)

PTP is characterized by thrombocytopenia arising 5-12 days following transfusion of

cellular blood components with findings of antibodies in the patient directed against the

Human Platelet Antigen (HPA) system.

Transfusion-associated

graft-versus-host disease

(Ta-GvHD)

TA-GvHD is a clinical syndrome characterised by symptoms of fever, rash, liver dysfunction,

diarrhoea, pancytopenia and findings of characteristic histological appearances on biopsy

occurring 1-6 weeks following transfusion with no other apparent cause. The diagnosis of

TA-GvHD is further supported by the presence of chimerism.

Transfusion-associated

cardiovascular overload

(TACO)

Patients classified with TACO (surveillance diagnosis) should exhibit the following during or

up to 12 hours after transfusion*

• At least one required criterion (i.e., A and/or B)

• With a total of at least 3 or more criteria (A to E)

*Required criteria (A and/or B) A. Acute or worsening respiratory deterioration and/or B. Evidence of acute or worsening pulmonary oedema based on:

- clinical physical examination, and/or - radiographic chest imaging and/or other non-invasive assessment of cardiac function

Additional criteria C. Evidence for cardiovascular system changes not explained by the patient’s underlying medical condition, including development of tachycardia, hypertension, jugular venous distension, enlarged cardiac silhouette and/or peripheral oedema

Haemovigilance Annual Report 2025 77

D. Evidence of fluid overload including any of the following: a positive fluid balance; clinical improvement following diuresis E. Supportive result of a relevant biomarker, e.g., an increase of B-type natriuretic peptide levels (BNP) or N-terminal-pro brain natriuretic peptide) NT-pro BNP to greater than 1.5 times the pre-transfusion value

Hypotensive transfusion

reaction

This reaction is characterized by hypotension defined as a drop in systolic blood pressure

of ≥ 30 mm Hg occurring during or within one hour of completing transfusion and a systolic

blood pressure ≤ 80 mm Hg. Most reactions do occur very rapidly after the start of the

transfusion (within minutes).

Transfusion-associated

dyspnoea (TAD)

TAD is characterized by respiratory distress within 24 hours of transfusion that do not meet

the criteria of TRALI, TACO, or allergic reaction. Respiratory distress should not be

explained by the patient’s underlying condition or any other known cause.

Non-immunological

haemolysis

Haemolysis due to physical, chemical, or mechanical factors, without involvement of

immune antibodies. Common causes include:

- Mechanical damage (e.g., improper warming, small‑bore needles, infusion pumps)

- Thermal injury (overheating/freezing of RBC)

- Osmotic injury (hypotonic solutions)

- Chemical exposure (incompatible IV fluids, drugs)

- Storage or transport conditions causing RBC membrane damage

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Annex 5. Additional information on SAE by specification

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Haemovigilance Annual Report 2025 80

Haemovigilance Annual Report 2025 81

Annex 6. Additional information on SAR in donors per reporting country

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Annex 7. SAR IL 1 (Voluntary)

6.1 Overview of SAR (IL 1) and fatalities (IL 1) by type of BC (2023 vs. 2024)

6.2 Overview of SAR (IL 1) by type of reaction (2023 vs. 2024)

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6.3 Overview of TTIs (IL 1)

Note: zero TTFI and TTPRI cases reported in both 2023 and 2024.

6.4 Overview of TTIs (IL 1) by type of BC; 2023 vs. 2024

Note 1: zero TTFI and TTPRI cases reported in both 2023 and 2024.

Note 2: zero TTIs reported in plasma or WB in both 2023 and 2024.

Note 3: in 2024, TTBI: RBC- (1) Serratia marcescens et Proteus mirabilis; (1) E.coli; (1) Bacillus cereus; (1) Streptococcus mitis

and Streptococcus oralis; (3) Klebsiella oxytoca, E. coli and Staphylococcus haemolyticus; Platelets- (1) Staphylococcus

warneri, (1) Staphylococcus hominis and Staphylococcus epidermidis, (1) Bacillus cereus, (1) Streptococcus dysgalactiae;

MTOC- (1) Staphylococcus aureus. TTVI: RBC- (1) HEV.

Haemovigilance Annual Report 2025 85

6.5 Overview of fatalities (IL 1) by type of BC and per reporting country; and by type reaction (2023

vs. 2024)

Two TTBI (IL 1) fatalities were reported:

• A severely ill patient with extensive comorbidity and pre‑existing sepsis deteriorated rapidly

after RBC transfusion. Bacterial culture from one RBC unit later showed growth of Yersinia

enterocolitica, a pathogen well recognised for proliferating at refrigerated temperatures.

Imputability remained IL1 due to possible reverse contamination from the patient.

• A patient developed septic shock shortly after transfusion of pooled platelets. Bacillus cereus

was isolated from both recipient blood cultures and one platelet unit. Imputability was IL1

because strain comparison or resistance profile was not performed.

Haemovigilance Annual Report 2025 86

Annex 8. Data Supplement – Donation rates of WB and apheresis per 1 000 population in the last four

years

(Refer to Figure 1, Figure 2, Figure 8 and Figure 9)

Note: cells highlighted in dark grey refer to countries not reporting for that data year while cells highlighted in light dark grey

refer to countries reporting data N/A.

Haemovigilance Annual Report 2025 87

Annex 9. Data Supplement – Issuance, transfusion and processing rates per 1 000 population in the last four years

(Refer to Figure 3, Figure 10 and Figure 11)

Note: cells highlighted in dark grey refer to countries not reporting for that data year while cells highlighted in light dark grey refer to countries reporting data N/A.

Haemovigilance Annual Report 2025 88

Annex 10. Data Supplement – Recipient rates regardless of type of BC per 1 000 population in the last

four years

(Refer to Figure 7 and Figure 12)

Note: cells highlighted in dark grey refer to countries not reporting for that data year while cells highlighted in light dark grey

refer to countries reporting data N/A.

Haemovigilance Annual Report 2025 89

Annex 11. Data Supplement – Transfusion rates pmp by type of BC (except MTOC) in the last four years

(Refer to Figure 4, Figure 5, Figure 6, Figure 13, Figure 14, Figure 15 and Figure 16)

Note: cells highlighted in dark grey refer to countries not reporting for that data year while cells highlighted in light dark grey refer to countries reporting data N/A.

Haemovigilance Annual Report 2025 90

Annex 12. Data Supplement - SAR (IL 2-3) and SAE incidence rates in the last four years

SAR (IL 2-3) incidence rates per 100 000 units transfused (Refer to Figure 17 and Figure 18)

SAE incidence rates per 100 000 units processed (Refer to Figure 24, Figure 25 and Figure 26)

Note: cells highlighted in dark grey refer to countries not reporting for that data year while cells highlighted in light dark grey

refer to countries reporting denominator data N/A (so incidence could not be calculated).

Haemovigilance Annual Report 2025 91

Annex 13. Data Supplement - SAR (IL 2-3) incidence rates/100 000 units transfused for each type of BC (excluding MTOC) in the last four years

(Refer to Figure 19)

Note 1: cells highlighted in dark grey refer to countries not reporting for that data year while cells highlighted in light dark grey refer to countries reporting denominator data N/A (so

incidence could not be calculated).

Note 2: also for WB- 2021 (NO) SAR rate of 362; 2023 (IT) SAR rate of 10 000; 2024 (NO) SAR rate of 233.

Haemovigilance Annual Report 2025 92

Annex 14. References

[1] Common Approach, version 2025; https://health.ec.europa.eu/document/download/ca7b4156-6b55-4768-

9c06-4ce59e77d69b_en?filename=btco_2025_blood_common-approach_en.pdf

[2] Narayan, S. et al., 2025. The 2024 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT)

SteeringGroup. https://doi.org/10.57911/gwcz-4q04

[3] 2024 Annual SHOT Report, Chapter 20a Transfusion-Associated Circulatory Overload (TACO) n=188,

https://www.shotuk.org/wp-content/uploads/2025/07/20a.-Transfusion-Associated-Circulatory-Overload-

TACO-2024.pdf