FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1031662
·
Received April 18, 2008
Report
- Report Number
- 6000001-2008-00256
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 10, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED BY BAXTER FOR EVAL, BUT HAS NOT YET BEEN REC'D. SHOULD THE PUMP BE REC'D FOR EVAL, A F/U REPORT WILL BE FILED UPON COMPLETION OF THE EVAL OR IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPORTED AN INFUSION PUMP THAT TURNED OFF AFTER POWER-UP (UNINTENDED SHUTDOWN). THE EVENT WAS REPORTED TO HAVE OCCURRED PRIOR TO USE. ACCORDING TO THE HOSP REP, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADD'L INFO OR CONTACT WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |