FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
MDR report key: 1863926
·
Received October 11, 2010
Report
- Report Number
- 6000001-2010-03943
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 17, 2010
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K063696
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 1
(B)(4). THERE WAS NOT A DEVICE INTERRUPTION DURING DELIVERY. THIS REPORT HAS BEEN RETRACTED SINCE IT IS NOT REPORTABLE.
Description of Event or Problem · 1
THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT A COLLEAGUE INFUSION PUMP THAT HAD A CHANNEL FAILURE. DURING THE PRODUCT EVALUATION, IT WAS DISCOVERED THAT THE CHANNEL A SELECT KEY WAS INOPERATIVE. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS CURRENTLY UNKNOWN FOR THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |