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