FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 1230579
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88652
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- June 11, 2007
- Report Date
- June 11, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: DURING EVALUATION REPORTED CONDITION OF OVER-INFUSION WAS CONFIRMED ON CHANNEL C DUE TO A DEFECTIVE PUMP HEAD MODULE (PHM). THE PUMP HEAD MODULE WAS REPLACED.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO BAXTER FOR SERVICE. DURING THE EVALUATION FOR REPAIR, THE TECHNICIAN NOTED AN INACCURACY IN WHICH, CHANNEL C WAS NOTED TO OVER INFUSE DURING TESTING. THERE WAS NO PATIENT INJURY NOR MEDICAL INTERVENTION REQUIRED TO PREVENT INJURY ASSOCIATED WITH THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |