FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1231058
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88530
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- May 1, 2007
- Report Date
- May 3, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE.LTD
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF A PUMP THAT TURNS ITSELF ON AND OFF WAS CONFIRMED DURING PRODUCT EVALUATION. THIS EVENT WAS CAUSED BY A FAULTY FRONT BEZEL. THE FRONT BEZEL WAS REPLACED.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE REPORTED AN INFUSION PUMP THAT TURNS ITSELF ON AND OFF. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE.LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |