FDA Adverse Event Death Summary report: N

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

MDR report key: 437384 · Received January 10, 2003

Report

Report Number
6000001-2003-00002
Event Type
Death
Date Received
January 10, 2003
Date of Event
December 13, 2002
Report Date
December 13, 2002
Manufacturer
BAXTER HEALTHCARE (SG)
Product Code
FRN
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
CO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

AN INFUSION PUMP WAS INVOLVED IN A PATIENT DEATH. AN INTENSIVE CARE UNIT NURSE REPORTED THAT NOREPINEPHRINE WAS PROGRAMMED "AT A HIGHER RATE" AND INFUSED "IN A SHORT AMOUNT OF TIME". THE PUMP WAS BEING USED ON AN INTENSIVE CARE UNIT PATIENT WHO WAS POST CORONARY ARTERY BYPASS GRAFT. THE FACILITY'S RISK MANAGEMENT DEPARTMENT REPORTED THAT AFTER THE PATIENT HAD ARRIVED FROM THE OPERATING ROOM, THE NURSE SET UP THE PUMP FOR INFUSION OF NOREPINEPHRINE. AFTER THE INFUSION WAS STARTED, THE PATIENT'S BLOOD PRESSURE (BP) INCREASED. THE NURSE NOTICED THE INCREASE IN BP AND TURNED OFF THE INFUSION OF NOREPINEPHRINE. BP STEADILY DECLINED AND THEN THE PATIENT WENT INTO CARDIOPULMONARY ARREST. THE PATIENT WAS NOT ABLE TO BE RESUSCITATED AND EXPIRED. THE RISK MANAGEMENT STATED THAT AN AUTOPSY HAD NOT BEEN PERFORMED AND THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. DESPITE BAXTER'S EFFORTS TO OBTAIN ADD'L INFO FROM THE RISK MANAGEMENT DEPT, DETAILS WERE NOT AVAILABLE REGARDING PT'S DEMOGRAPHICS OR DIAGNOSIS, THE CAUSE OF PT'S DEATH, MEDICATION INVOLVED, OR SET UP OF THE INFUSION DEVICE.

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 80 YR Death