# Commission 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 (Text with EEA relevance), Part D: Annual notification format for serious adverse reactions

Extent: E+W+S+N.I.

Reporting establishment
Reporting period
This Table refers to[ ] Whole blood [ ] Red blood cells [ ] Platelets [ ] Plasma [ ] Other (use separate table for each component)
Number of units issued (total number of units issued with a given number of blood components)
Number of recipients transfused (total number of recipients transfused with a given number of blood components) (if available)
Number of units transfused (the total number of blood components (units) transfused over the reporting period) (if available)
Total number reported
Number of serious adverse reactions with imputability level 0 to 3 after confirmation (see Annex IIA)
Number of deaths
not assessable
Level0
Level1
Level2
Level3
Immunological Haemolysis
Due to ABO incompatibility
Total
Deaths
Due to other allo-antibody
Total
Deaths
Non-immunological haemolysis
Total
Deaths
Transfusion-transmitted bacterial infection
Total
Deaths
Anaphylaxis/hypersensitivity
Total
Deaths
Transfusion related acute lung injury
Total
Deaths
Transfusion-transmitted viral Infection
HBV
Total
Deaths
HCV
Total
Deaths
HIV-1/2
Total
Deaths
Other (specify)
Total
Deaths
Transfusion-transmitted parasitical infection
Malaria
Total
Deaths
Other (specify)
Total
Deaths
Post-transfusion purpura
Total
Deaths
Graft versus host disease
Total
Deaths
Other serious reactions (specify)
Total
Deaths

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Source: https://www.legislation.gov.uk/eudr/2005/61/annex/II/part/D (the official version)
Page: https://openlegislation.uk/eu-directive-2005-61/annex-II/part-D
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.