OtherKII
MDR event
Received Aug 25, 2006
Report 9616240-2006-00430 · MDR key 974537
Device
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
Not reported
- Coagulation
- Blood Loss
Narrative
Additional Manufacturer Narrative
THE PATIENT DID NOT SUFFER AN INJURY NOR REQUIRE MEDICAL INTERVENTION FOR THIS BLOOD LOSS. ACCORDING TO THE FINAL CLINICAL REPORT THIS PT IS A LONG TERM CHRONIC PT AT THIS FACILITY AND HAS AN ESTABLISHED HEPARINIZATION PROGRAM. THE CLOTTING MAY HAVE BEEN DUE TO THE PT'S HIGH HEMOGLOBIN. NO SERIAL NUMBER OF THE MACHINE WAS PROVIDED.