FDA Adverse Event
Malfunction
Summary report: N
PCA II PUMP
MDR report key: 1243111
·
Received November 21, 2008
Report
- Report Number
- 6000001-2008-00779
- Event Type
- Malfunction
- Date Received
- November 21, 2008
- Date of Event
- November 3, 2008
- Report Date
- November 4, 2008
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- MEA
- PMA / PMN Number
- K926385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE HAS BEEN RECEIVED IN BAXTER, BUT HAS NOT YET BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AN EVALUATION IS COMPLETED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A PUMP THAT FAILS TO ALARM AT THE 5ML LEVEL AS INTENDED. THIS EVENT OCCURRED DURING BIOMED TESTING. NO PT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PCA II PUMP | 80FRN | MEA | BAXTER HEALTHCARE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |