FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 1233190
·
Received November 18, 2008
Report
- Report Number
- 6000001-2007-04341
- Event Type
- Malfunction
- Date Received
- November 18, 2008
- Date of Event
- January 17, 2007
- Report Date
- January 17, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF THE DEFECTIVE AIR IN LINE PRINTED CIRCUIT BOARD WAS CONFIRMED. DURING SERVICE, THE BAXTER TECHNICIAN FOUND A FAIL CODE 814:04 IN THE EVENT HISTORY. THIS FAILURE CODE IS MANIFESTED AS A LINE PRINTED CIRCUIT BOARD WAS REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.
Description of Event or Problem · 1
THE FACILITY RETURNED THE DEVICE FOR SERVICE. DURING PRODUCT EVALUATION, THE BAXTER TECHNICIAN FOUND A DEFECTIVE AIR IN LINE PRINTED CIRCUIT BOARD. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |