FDA Adverse Event
Malfunction
Summary report: N
6464602R PCA II PUMP REFURBISHED
MDR report key: 1030320
·
Received April 16, 2008
Report
- Report Number
- 6000001-2008-00245
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 26, 2008
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FRN
- PMA / PMN Number
- K926385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RECIEVED 03/28/08, AND IS BEING EVALUATED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED, WHEN THE EVALUATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE FACILITY REP REPORTED A PUMP OBSERVED THAT FAILS TO ALARM WHEN THE PT-CONTROLLED ANALGESIA IS PUSHED FOR A DOSE. THIS EVENT OCCURRED AT AN UNK TIME. 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 | 6464602R PCA II PUMP REFURBISHED | 80FRN | FRN | BAXTER HEALTHCARE CORP. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |