MalfunctionFJG
AN-69
Received Oct 10, 1999 · Event occurred Sep 8, 1999
Report 8010182-1999-00021 · MDR key 244433
Device
Product problems
- Fluid/Blood Leak
Patient
UNKNOWN
- Blood Loss
Narrative
Description of Event or Problem
PT #1. BLOOD LEAK TO ATMOSPHERE FROM THE DIALYZER HEADER APPROX 10 MINS INTO THE TREATMENT. BLOOD LOSS WAS ESTIMATED AT 5-10 CC. THERE WAS NO PT INJURY OR MED INTERVENTION. NO EVIDENCE OF CRACKING WAS FOUND DURING PRIME.
Remedial action
- Other