FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 493708
·
Received September 16, 2002
Report
- Report Number
- 6000001-2002-03535
- Event Type
- Malfunction
- Date Received
- September 16, 2002
- Date of Event
- August 1, 2002
- Report Date
- August 20, 2002
- Manufacturer
- BAXTER HEALTHCARE (SG)
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE FACILITY'S BIOMED ENGINEER REPORTED AN INFUSION PUMP WITH 810:011. INFORMATION WAS REQUESTED BY BAXTER REGARDING WHETHER OR NOT THE PUMP WAS IN USE ON A PATIENT WHEN THE FAILURE OCCURRED, SPECIFIC PATIENT INFORMATION, WHETHER OR NOT THERE WAS A REPORT OF MEDICAL INTERVENTION OR PATIENT INJURY, PUMP PROGRAMMING AND SET-UP INFORMATION, TUBING PRODUCT CODE AND LOT NUMBER IN USE AND THE MEDICATION INVOLVED IF APPLICABLE, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL CONTACT INFORMATION WAS REQUESTED BUT NO ADDITIONAL CONTACT WAS IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE (SG) | COLLEAGUE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |