FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1231476
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-05247
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- February 9, 2007
- Report Date
- March 12, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE.LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
FACILITY REPORTED A PUMP FAILURE DURING AN INFUSION OF IV INOTROPIC SUPPORT (DOPAMINE, MILRINONE) FOR A POST-OP, OPEN CHEST, REDO OF MITRAL VALVE REPLACEMENT. THE PUMP FAILED DURING INFUSION AND SHOWED "FAILED" ALARMS AND LIGHTS. THERAPY WAS INTERRUPTED UNTIL A NEW PUMP COULD BE FOUND. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE.LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |