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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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ANNEX IIINOTIFICATION OF SERIOUS ADVERSE EVENTS
PART ARapid Notification Format for Serious Adverse Events
Reporting establishment
Report identification
Reporting date (year/month/day)
Date of serious adverse event (year/month/day)
| 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(specify) | |
| Whole blood collection | ||||
| Apheresis collection | ||||
| Testing of donations | ||||
| Processing | ||||
| Storage | ||||
| Distribution | ||||
| Materials | ||||
| Others (specify) | ||||
PART BConfirmation Format for Serious Adverse Events
Reporting establishment
Report identification
Confirmation date (year/month/day)
Date of serious adverse event (year/month/day)
Root cause analysis (details)
Corrective measures taken (details)
PART CAnnual Notification Format for Serious Adverse Events
Reporting establishment
| Reporting period | 1 January-31 December (year) |
Total number of blood and blood components processed:
| 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(specify) | ||
| Whole blood collection | |||||
| Apheresis collection | |||||
| Testing of donations | |||||
| Processing | |||||
| Storage | |||||
| Distribution | |||||
| Materials | |||||
| Others (specify) | |||||
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