Imputability level Explanation NA Not assessable When there is insufficient data for 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 or blood components. 1 Possible When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes. 2 Likely, Probable When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component. 3 Certain When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.
This Table refers to[ ] Whole blood
[ ] Red blood cells
[ ] Platelets
[ ] Plasma
[ ] Other
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) Number of units transfused (the total number of blood components (units) transfused over the reporting period) 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 Total Deaths Transfusion-transmitted parasitical infection Malaria Total Deaths Other Total Deaths Post-transfusion purpura Total Deaths Graft versus host disease Total Deaths Other serious reactions Total Deaths
Serious adverse event, which may affect quality and safety of blood component due to a deviation in:
Specification
Product defect Equipment failure Human error Other Whole blood collection Apheresis collection Testing of donations Processing Storage Distribution Materials Others
Serious adverse event, affecting quality and safety of blood component due to a deviation in:
Total number
Specification
Product defect Equipment failure Human error Other Whole blood collection Apheresis collection Testing of donations Processing Storage Distribution Materials Others