FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
MDR report key: 2061484
·
Received April 18, 2011
Report
- Report Number
- 6000001-2011-02945
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- January 10, 2011
- Report Date
- April 3, 2011
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K041191
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- 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). ACCORDING TO THE PRODUCT ANALYSIS LAB AT BAXTER ON (B)(4) 2011, THE EVENT HISTORY DID NOT HAVE ANY FAILURE CODES NOTED.
Description of Event or Problem · 1
DURING BAXTER'S REVIEW OF THE EVENT HISTORY OF ANOTHER REPORT, IT WAS DISCOVERED THAT FAILURE CODE 810:04 OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE WAS NO ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |