FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE THIPLE CHANNEL VOLUMETRIC INFUSION PUMP
MDR report key: 1231414
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88364
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- May 31, 2007
- Report Date
- May 31, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE.LTD
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF THE PUMP THAT TURNS ON AND OFF BY ITSELF COULD NOT BE CONFIRMED DURING PRODUCT EVALUATION. THEREFORE NO ADDITIONAL ACTION WAS NECESSARY.
Description of Event or Problem · 1
THE FACILITY REPORTED A PUMP THAT TURNS ITSELF OFF. THESE PROBLEMS OCCURRED DURING BIOMED TESTING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE THIPLE CHANNEL VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE.LTD | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |