FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
MDR report key: 1240243
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-06187
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 17, 2007
- Report Date
- April 17, 2007
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Removal / Correction Number
- 2005-047-MD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: DURING PRODUCT EVALUATION, A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD (UIM PCB) WAS OBSERVED. FAILURE CODE 703 IN THE EVENT HISTORY CONFIRMS THE DEFECTIVE UIM PCB. THIS FAILURE CODE IS MANIFESTED AS A RESULT OF THE UIM PCB BEING DEFECTIVE. THE UIM PCB WAS REPLACED.
Description of Event or Problem · 1
THE PUMP WAS RETURNED TO BAXTER FOR PHYSICAL DAMAGE REPAIRS. DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN A DEFECTIVE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE (SG) | N/A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |