FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1023056
·
Received April 3, 2008
Report
- Report Number
- 6000001-2007-02110
- Event Type
- Malfunction
- Date Received
- April 3, 2008
- Date of Event
- August 31, 2006
- Report Date
- August 31, 2006
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Removal / Correction Number
- CONTINUED ON H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: FAILURE CODE WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS FAILURE CODE WAS CAUSED BY DEPLETED BATTERIES, THEREFORE THE PUMP'S BATTERIES WERE REPLACED. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION, FAILURE CODE 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 |