FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
MDR report key: 1232096
·
Received November 7, 2008
Report
- Report Number
- 6000001-2008-00734
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- September 28, 2008
- Report Date
- October 7, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K063696
- Removal / Correction Number
- UPGRADED PUMP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF TUBE LOAD FAILURE WAS CONFIRMED DURING EVALUATION. THIS WAS DETERMINED TO HAVE BEEN CAUSED BY AN INOPERATIVE OPEN KEY ON THE KEYPAD'S PUMP HEAD MODULE. THE PUMP HEAD MODULE WAS REPLACED TO RESOLVE THE REPORTED CONDITION. THE DEVICE WAS TESTED, AND RETURNED WITHIN SPECIFICATION.
Description of Event or Problem · 1
THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP IN WHICH THE TUBE WOULD NOT LOAD. THIS WAS IDENTIFIED DURING BIOMEDICAL TESTING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE CX VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |