FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 1240070
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-06000
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 1, 2007
- Report Date
- April 6, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILED CHANNELS AND OVER INFUSION WAS NOT CONFIRMED DURING BIOMED TESTING. THE INFUSION PUMP WAS TESTED FOR FLOW ACCURACY AT 100 ML/HOUR, THE INFUSION PUMP MET THE ACCURACY TEST. THE SPECIFICATION OF THIS DEVICE IS +/-5%.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED A DEVICE THAT ALL CHANNELS FAILED AND OVER INFUSED DURING BIOMED TESTING. THE HOSPITAL REPRESENTATIVE DID NOT HAVE INFORMATION REGARDING WHETHER THERE HAVE BEEN ANY REPORTS OF ANY PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |