FDA Adverse Event
Malfunction
Summary report: N
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
MDR report key: 1051223
·
Received May 23, 2008
Report
- Report Number
- 6000001-2008-00340
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 5, 2008
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD
- Product Code
- FRN
- PMA / PMN Number
- K010566
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVAL, OR IF ANY ADD'L DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER AT THIS TIME.
Description of Event or Problem · 1
THE FIELD SERVICE ENGINEER REPORTED A PUMP THAT WENT INTO FAILURE AND DISPLAYED FAILURE CODE 570:320:844:0000 DURING THE ADMINISTRATION OF NOREPINEPHRINE, CISATRACURIUM, LORAZEPAM, FENTANYL, PACKED RED BLOOD CELLS, AND SODIUM BICARBONATE. THE PT WAS A FEMALE. PER THE HOSPITAL REP, THERE WAS NO PT INJURY. THE PUMP WAS SWAPPED OUT FOR ANOTHER PUMP. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP | 80FRN | FRN | BAXTER HEALTHCARE PTE. LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |