FDA Adverse Event Death Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 427288 · Received November 12, 2002

Report

Report Number
6000001-2002-05226
Event Type
Death
Date Received
November 12, 2002
Date of Event
October 1, 2002
Report Date
October 15, 2002
Manufacturer
BAXTER HEALTHCARE (SG)
Product Code
FRN
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A MEMBER OF THE FACILITY'S NURSING STAFF REPORTED THAT A PATIENT DEATH OCCURRED AFTER A FAILURE WITH A COLLEAGUE INFUSION PUMP. UPON FURTHER INVESTIGATION WITH THE FACILITY, THE PATIENT WAS REPORTED TO BE A CARDIAC TRANSPLANT PATIENT THAT WAS IN THE CARDIOVASCULAR INTENSIVE CARE UNIT. A TRIPLE CHANNEL PUMP WAS IN USE INFUSING ISOPROTERENOL AT AN UNKNOWN RATE. THE NURSE REPORTED THAT PUMP WENT INTO AN UNKNOWN FAILURE. THE PATIENT CODED AND WAS RESUSCITATED BY THE MEDICAL STAFF. THE ASSISTANT NURSE MANAGER REPORTS THE PATIENT DID EXPIRE 12 HOURS AFTER THE PUMP FAILURE AND STATED THAT THE DEATH WAS NOT RELATED TO THE INCIDENT WITH THE PUMP. THE PUMP WAS NOT IDENTIFIED OR ISOLATED BY THE FACILITY. ALTHOUGH ATTEMPTS WERE MADE BY BAXTER SALES AND QUALITY MANAGEMENT TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PATIENT DEMOGRAPHICS, STATUS, OR SET UP OF THE DEVICE. THE ASSISTANT NURSE MANAGER STATED THAT AN AUTOPSY WAS NOT PERFORMED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) COLLEAGUE 3CX NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Death| L| R