FDA Adverse Event
Malfunction
Summary report: N
UO605 6464602 PCA II PUMP
MDR report key: 1230648
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88712
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- June 1, 2007
- Report Date
- June 25, 2007
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K926385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: DEVICE HAS BEEN REQUESTED FOR EVALUATION. IF DEVICE IS RECEIVED AND AN EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
CUSTOMER REPORTED BATTERY ACID WAS FOUND INSIDE THE PUMP. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. ALTHOUGH REQUESTED, NO ADDITIONAL INFORNMATION HAS BEEN OBTAINED ON THIS REPORT. NO PATIENT INVOLVEMENT HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UO605 6464602 PCA II PUMP | 80FRN | FRN | BAXTER HEALTHCARE CORPORATION | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |