FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUION PUMP
MDR report key: 1408327
·
Received June 26, 2009
Report
- Report Number
- 6000001-2009-00606
- Event Type
- Malfunction
- Date Received
- June 26, 2009
- Date of Event
- May 14, 2009
- Report Date
- May 14, 2009
- Manufacturer
- BAXTER HEALTHCARE PTE LTD
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH "FAILURE CODE 12:322:1894:0001." THE REPORTED FAILURE CODE OCCURRED DURING PT INFUSION, WHICH RESULTED IN AN INTERRUPTION OF THERAPY. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION REPORTED. THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.04.00 THAT IS CATEGORIZED AS "UNREMEDIATED". THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE CX VOLUMETRIC INFUION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |