FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
MDR report key: 1130083
·
Received August 19, 2008
Report
- Report Number
- 6000001-2008-00473
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 4, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION, OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPORTED TO CUSTOMER SERVICE A PUMP THAT WAS SMOKING. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION 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 |