FDA Adverse Event
Malfunction
Summary report: N
ZIMMER BLOOD REINFUSION SYSTEM
MDR report key: 2122039
·
Received May 24, 2011
Report
- Report Number
- 1526350-2011-00104
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 12, 2011
- Report Date
- April 22, 2011
- Manufacturer
- ZIMMER SURGICAL
- Product Code
- CAC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE NURSE WAS USING THE ZIMMER BLOOD REINFUSION SYSTEM IN THE OPERATING ROOM, THE COLLECTION RESERVOIR WAS LEAKING BY A PUNCTURE HOLE. SURGERY WAS DELAYED FOR 30-40 MINUTES AND SURGERY WAS COMPLETED WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER BLOOD REINFUSION SYSTEM | HEMOVAC BLOOD REINFUSION SYSTEM | CAC | ZIMMER SURGICAL | NA | 61363131 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |