FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 1150133
·
Received August 29, 2008
Report
- Report Number
- 6000001-2008-00511
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- August 19, 2008
- Report Date
- August 19, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 EVAL, OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.
Description of Event or Problem · 1
THE FACILITY REPORTED AN INFUSION PUMP THAT WAS RUNNING AT A RATE OF 53 ML/HR BUT WAS SET TO RUN AT A RATE OF 50 ML/HR ON CHANNEL B. THIS CONDITION OCCURRED DURING BIO-MED TESTING. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSP REP. NO ADDITIONAL INFO IS AVAILABLE.
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 |