FDA Adverse Event
Malfunction
Summary report: N
U0605 6464602 PCA II PUMP
MDR report key: 1030319
·
Received April 16, 2008
Report
- Report Number
- 6000001-2008-00246
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 31, 2008
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- MEA
- PMA / PMN Number
- K926385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF, AND WHEN DEVICE IS RECEIVED AND AN EVALUATION HAS BEEN PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A PUMP OBSERVED THAT OVERINFUSED AND DID NOT RECORD THE EVENT IN THE HISTORY. THIS EVENT OCCURRED DURING PT USE. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | U0605 6464602 PCA II PUMP | 80FRN | MEA | BAXTER HEALTHCARE CORP. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |