FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
MDR report key: 707579
·
Received November 22, 2005
Report
- Report Number
- 6000001-2005-07092
- Event Type
- Malfunction
- Date Received
- November 22, 2005
- Date of Event
- November 1, 2005
- Report Date
- November 2, 2005
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A FAILURE CODE 12:303:984:0002 ON THIS COLLEAGUE INFUSION DEVICE. NO RECORD OF ANY PT INCIDENT INVOLVING THE PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3 VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | COLLEAGUE 3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |