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Commission Directive 2005/61/ECShow full title
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)
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PART ARapid notification format for suspected serious adverse reactions
Reporting establishment
Report identification
Reporting date (year/month/day)
Date of transfusion (year/month/day)
Age and sex of recipient
Date of serious adverse reaction (year/month/day)
Serious adverse reaction is related to
Whole blood
Red blood cells
Platelets
Plasma
Other (specify)
Type of serious adverse reaction(s)
Immunological haemolysis due to ABO incompatibility
Immunological haemolysis due to other allo-antibody
Non-immunological haemolysis
Transfusion-transmitted bacterial infection
Anaphylaxis/hypersensitivity
Transfusion related acute lung injury
Transfusion-transmitted viral infection (HBV)
Transfusion-transmitted viral infection (HCV)
Transfusion-transmitted viral infection (HIV-1/2)
Transfusion-transmitted viral infection, Other (specify)
Transfusion-transmitted parasitical infection (Malaria)
Transfusion-transmitted parasitical infection, Other (specify)
Post-transfusion purpura
Graft versus host disease
Other serious reaction(s) (specify)
Imputability level (NA, 0-3)
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