FDA Adverse Event Death Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 442115 · Received February 4, 2003

Report

Report Number
6000001-2003-01187
Event Type
Death
Date Received
February 4, 2003
Date of Event
December 20, 2002
Report Date
January 6, 2003
Manufacturer
BAXTER HEALTHCARE PTE. LTD.
Product Code
FRN
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THE FACILITY'S RISK MANAGEMENT DEPARTMENT REPORTED THAT A COLLEAGUE INFUSION PUMP WAS INVOLVED IN A PATIENT DEATH. MAGNESIUM SULFATE WAS BEING INFUSED AT APPROXIMATE RATE OF 2-2.5ML/HR IN A PIGGYBACK INFUSION WITH A PRIMARY INFUSION OF LACTATED RINGERS TO A PT. THE PUMP BEEPED "DOWNSTREAM OCCLUSION" AND THE NURSE REPORTEDLY REMOVED TUBING FROM THE CHANNEL FOR TROUBLESHOOTING. WHILE CHECKING THE TUBING, THE NURSE NOTICED THAT THE BAG OF MAGNESIUM SULFATE WAS EMPTY. THE NURSE GOT A NEW BAG, SPIKED THE BAG, AND HUNG IT ON THE IV POLE WITH THE TUBING OUTSIDE OF THE PUMP CHANNEL. THE PATIENT THEN HAD TO USE THE BATHROOM. WHEN THE NURSE RETURNED TO THE ROOM, THE PATIENT WAS BARELY CONSCIOUS AND THE NEW BAG OF MAGNESIUM SULFATE WAS ALMOST EMPTY. THE BAG CONTAINED 20GM OF MAGNESIUM SULFATE AND REPORTEDLY INFUSED IN 10 MINUTES OR LESS. THE PATIENT PROGRESSED TO CARDIOPULMONARY ARREST. RISK MANAGEMENT REPORTED THAT THE PATIENT WAS NOT ABLE TO BE RESUSCITATED AND EXPIRED. DESPITE BAXTER'S EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PATIENT'S DEMOGRAPHICS AND DIAGNOSIS, THE PRIMARY OR SECONDARY CAUSE OF DEATH, RATES OF OTHER MEDICATION INVOLVED.

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 3C NA

Patients

Seq Age Sex Outcome Treatment
1 24 YR Death BAXTER IV ADMINISTRATION SET, PRODUCT CODE UNKNOWN