Below are detailed descriptions of reportable adverse events, grouped by state or federal agency. Answer the question that appears beneath EACH description. When you're finished, click View Reporting Instructions to move to the next page.
The FDA requires you to report fatal complications of blood collection or transfusion.
(This requirement applies to facilities that collect, process, compatibility test, store, or distribute blood or blood components).
Facilities that perform blood compatibility testing should report fatal transfusion reactions, and facilities that collect blood should report fatal donor reactions. In this context, "compatibility testing" is the procedures performed to establish the matching of a donor's blood or blood components with that of a potential recipient.
If you determine that a blood product was at fault in a transfusion reaction, even if the reaction was not fatal, you must submit a copy of your findings to the manufacturer or collecting facility.
Reference: 21 CFR § 606.170. For definitions, see 21 CFR § 606.3.
