FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 981372
·
Received October 5, 2007
Report
- Report Number
- 8010182-2007-00010
- Event Type
- Malfunction
- Date Received
- October 5, 2007
- Manufacturer
- *
- Product Code
- FJK
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT WITH THE FILTER POD OCCURRED DURING THE UNLOADING OF THE PRISMA SET. THE INCIDENT DID NOT RESULT IN ANY INJURY AND SINCE A PT WAS NOT CONNECTED TO THE DEVICE DURING UNLOADING, THERE IS NO RISK OF HARM TO A PT. NO FURTHER ACTION WILL BE TAKEN BY GAMBRO INDUSTRIES. NEVERTHELESS, WE WILL CONTINUE TO MONITOR AND TREND THIS TYPE OF DEFECT TO DETERMINE IF THERE ARE OPPORTUNITIES TO FURTHER REDUCE THE BREAKAGE RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | FJK | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |