FDA Adverse Event
Malfunction
Summary report: N
RE-MANUFACTURED IPUMP
MDR report key: 3152071
·
Received September 15, 2008
Report
- Report Number
- 6000001-2008-00534
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 26, 2008
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- PMA / PMN Number
- K052973
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE ACTUAL DEVICE IN THIS INCIDENT WAS RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF EVALUATION BECOME AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A PUMP OBSERVED WITH A FALSE OCCLUSION ALARM. THE ALARM CAUSES THE PUMP TO STOP FUNCTIONING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE REPORTER DOES NOT HAVE ADDITIONAL INFORMATION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. THE DEVICE WAS SENT TO BAXTER FOR EVALUATION AND REPAIR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RE-MANUFACTURED IPUMP | 80FRN | FRN | BAXTER HEALTHCARE (SG) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |