FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE VOLUMETRIC INFUSION PUMP
MDR report key: 1230623
·
Received November 17, 2008
Report
- Report Number
- 6000001-2007-88688
- Event Type
- Malfunction
- Date Received
- November 17, 2008
- Date of Event
- June 13, 2007
- Report Date
- June 13, 2007
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Removal / Correction Number
- 2006-0028-MD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: DURING EVALUATION OF THE PUMP THE AIR-IN-LINE PRINTED CIRCUIT BOARD (PCB) FAILED TESTING AND CALIBRATION. THE AIR-IN-LINE PCB WAS DETERMINED TO BE DEFECTIVE. THE AIR-IN-LINE PCB WAS REPLACED AND THE PUMP WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL.
Description of Event or Problem · 1
DURING SERVICE BY BAXTER, THE INFUSIOIN PUMP'S AIR-IN-LINE PRINTED CIRCUIT BOARD FAILED TESTING AND CALIBRATION. ACCORDING TO THE HOSPITAL REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE.
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 |