Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/... (32005L0061) - 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) - Seite 11

PART C

Confirmation format for serious adverse reactions

Reporting establishment

Report identification

Confirmation date (year/month/day)

Date of serious adverse reaction (year/month/day)

Confirmation of serious adverse reaction (Yes/No)

Imputability level (NA, 0-3)

Change of type of serious adverse reaction (Yes/No)

If Yes,

specify

Clinical outcome (if known)

— Complete recovery

— Minor sequelae

— Serious sequelae

— Death

PART D

Annual notification format for serious adverse reactions

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	Level 0	Level 1	Level 2	Level 3
Immunological Haemolysis	Due to ABO incompatibility	Total
	Due to ABO incompatibility	Deaths
	Due to other allo-antibody	Total
	Due to other allo-antibody	Deaths
Non-immunological haemolysis		Total
Non-immunological haemolysis		Deaths
Transfusion-transmitted bacterial infection		Total
Transfusion-transmitted bacterial infection		Deaths
Anaphylaxis/hypersensitivity		Total
Anaphylaxis/hypersensitivity		Deaths
Transfusion related acute lung injury		Total
Transfusion related acute lung injury		Deaths
Transfusion-transmitted viral Infection	HBV	Total
	HBV	Deaths
	HCV	Total
	HCV	Deaths
	HIV-1/2	Total
	HIV-1/2	Deaths
	Other (specify)	Total
	Other (specify)	Deaths
Transfusion-transmitted parasitical infection	Malaria	Total
	Malaria	Deaths
	Other (specify)	Total
	Other (specify)	Deaths
Post-transfusion purpura		Total
Post-transfusion purpura		Deaths
Graft versus host disease		Total
Graft versus host disease		Deaths
Other serious reactions (specify)		Total
Other serious reactions (specify)		Deaths