FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP
MDR report key: 1230642
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88723
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- June 18, 2007
- Report Date
- June 18, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF A PUMP FAILING AN AIR-IN-LINE TEST WAS CONFIRMED DURING PRODUCT EVALUATION. THE PUMP WAS THUS OUT OF SPECIFICATION. THE PUMP HEAD MECHANISM WAS REPLACED DURING SERVICE. PUMP WAS SERVICED IN THE FIELD ON 18 JUNE 2007.
Description of Event or Problem · 1
DURING FIELD SERVICE, THE BAXTER TECHNICIAN REPORTED AN INFUSION PUMP WITH THAT FAILED AN AIR-IN-LINE TEST DURING TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |