FDA Adverse Event
Malfunction
Summary report: N
PCA LL PUMP
MDR report key: 1240069
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-05991
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 1, 2007
- Report Date
- April 19, 2007
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATTERY LEAKING WAS FOUND DURING SERVICE. CORROSION WAS FOUND ON THE MECHANICAL BOARD AND MPU BOARD. PUMP WAS RETURNED UNREPAIRED PER THE CUSTOMERS REQUEST.
Description of Event or Problem · 1
DURING SERVICE BATTERY LEAKAGE WAS FOUND ON PUMP. BATTERY CORROSION WAS FOUND ON MPU BOARD AND MECHANICAL BOARD. BAXTER TECHNICIAN RECOMMENDED CUSTOMER USE RECHARGEABLE BATTERIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PCA LL PUMP | ANESTHESIA PUMPS | FRN | BAXTER HEALTHCARE | N/A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |