FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1240050
·
Received November 24, 2008
Report
- Report Number
- 6000001-2007-06047
- Event Type
- Malfunction
- Date Received
- November 24, 2008
- Date of Event
- April 1, 2007
- Report Date
- April 9, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF A PUMP THAT WAS NOT WORKING WAS NOT CONFIRMED DURING PRODUCT EVALUATION. THEREFORE, NO FURTHER CORRECTION WAS MADE. DEVICE WAS EVALUATED ON SITE IN 2007.
Description of Event or Problem · 1
THE FIELD SERVICE ENGINEER REPORTED A PUMP THAT WAS NOT WORKING. THIS PROBLEM WAS IDENTIFIED DURING PATIENT USE. 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 |