FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
MDR report key: 1023135
·
Received April 3, 2008
Report
- Report Number
- 6000001-2007-00406
- Event Type
- Malfunction
- Date Received
- April 3, 2008
- Date of Event
- December 1, 2006
- Report Date
- December 11, 2006
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Removal / Correction Number
- 600000-3/15/05-007-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE REPORTED CONDITION OF FAILURE CODE 810:11 WAS CONFIRMED. INSPECTION OF THE DEVICE FOUND THAT THIS WAS CAUSED BY THE PUMP'S AIR IN LINE PRINTED CIRCUIT BOARD BEING OUT OF SPECIFICATION. THIS PART WAS RECALIBRATED.
Description of Event or Problem · 1
A BAXTER ENGINEER REPORTED A PUMP WITH FAILURE CODE 810:11. IT IS UNKNOWN WHEN THIS OCCURRED. 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 CX VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |