FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
MDR report key: 1172670
·
Received September 19, 2008
Report
- Report Number
- 6000001-2008-00552
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 16, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K063696
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVAL, A F/U REPORT WILL BE FILED UPON COMPLETION OF AN EVAL, OR IF ANY ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPORTED A PUMP IN WHICH THE KEYPAD ON THE PUMP HEAD MODULE (PHM) IS NOT WORKING. IT IS UNK WHEN THIS EVENT OCCURRED. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE CX VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |