FDA Adverse Event
Death
Summary report: N
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
MDR report key: 575495
·
Received February 22, 2005
Report
- Report Number
- 6000001-2005-00462
- Event Type
- Death
- Date Received
- February 22, 2005
- Date of Event
- September 12, 2004
- Report Date
- January 31, 2005
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
"VERY III PT ON BAXTER PUMP WHICH ALARMED DUE TO MASSIVE SYSTEM FAILURE. HAD BRADYCARDIA, SEVER HYPOTENSION, GIVEN EPI RESPONDED BRIEFLY THEN ASYSTOLE. BECAME DO NOT RESUSCITATE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | COLLEAGUE 3CX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |