MalfunctionORG
CER-PRP-TRIPLE PLATELET TRIPLE
Received Mar 27, 2023
Report 1211566-2023-00005 · MDR key 16619820
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BLOOD LEAKED PAST THE O-RINGS DURING THE CENTRIFUGATION PROCESS.
Additional Manufacturer Narrative
DEVICE WAS EVALUATED, AND THE O-RING WAS FOUND TO BE ROLLED OVER CAUSED BY A MANUFACTURING ERROR.