FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 1130063
·
Received August 19, 2008
Report
- Report Number
- 6000001-2008-00476
- Event Type
- Malfunction
- Date Received
- August 19, 2008
- Date of Event
- May 12, 2008
- Report Date
- July 25, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: 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 REPORTED TO LARGO CUSTOMER SERVICE A PUMP WITH FAILURE CODE 812:00 ON CHANNELS A AND C. WHEN THE PUMP ALARMED, IT STOPPED INFUSING ON BOTH CHANNELS A AND C. THE NURSE STOPPED THERAPY, SWAPPED OUT THE PUMP AND CONTINUED THERAPY. THIS PROBLEM WAS IDENTIFIED DURING PATIENT USE. NO PATIENT INJURY OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |