FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1023027
·
Received April 3, 2008
Report
- Report Number
- 6000001-2007-01924
- Event Type
- Malfunction
- Date Received
- April 3, 2008
- Date of Event
- July 13, 2006
- Report Date
- July 13, 2006
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: FAILURE CODE 812:02 WAS CONFIRMED BUT COULD NOT BE DUPLICATED DURING SERVICE, THEREFORE THERE WERE NO CORRECTIONS MADE TO THE DEVICE FOR THIS FAILURE CODE.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION, FAILURE CODE 812:02 WAS FOUND IN THE PUMP'S EVENT HISTORY. 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 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |