BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 633272 · Received September 2, 2005

    Report

    Report Number
    6000001-2005-03643
    Event Type
    Death
    Date Received
    September 2, 2005
    Date of Event
    August 8, 2005
    Report Date
    August 8, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-2/25/05-004-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ON JANUARY 31, 2005, BAXTER RECEIVED A COPY OF THE USER FACILITY REPORT #1402330000-2005-8004, PROVIDING THE FOLLOWING ADDITIONAL INFORMATION: "THE PATIENT SUFFERED MASSIVE HEAD TRAUMA IN A HIGH SPEED MOTOR VEHICLE IN WHICH THE PATIENT WAS RIDING. PUPILS WERE FIXED AND DILATED AT THE SCENE, AND THERE WAS NO GAG REFLUX WITH INTUBATION. GLASGOW COMA SCALE WAS 3. PATIENT WAS HELICOPTERED TO THE HOSPITAL WITH BLUNT CHEST TRAUMA AND OPEN PELVIC FRACTURE, IN ADDITION TO HEAD INJURIES. AFTER EVALUATION, EMERGENCY LAPAROTOMY WAS PERFORMED FOR REPAIR OF A SMALL LIVER LACERATION AND TO EVALUATE OTHER IN INTERNAL INJURIES. FOLLOWING SURGERY, THE PATIENT REMAINED UNRESPONSIVE AND WAS TRANSFERRED TO THE ICU. THE FAILURE AT ISSUE OCCURRED AFTER SURGERY, DURING THE TRANSFER FROM THE OPERATING ROOM TO ICU. AT THE TIME OF THIS TRANSPORT, THE PATIENT WAS ON DOPAMINE INFUSION FOR BP SUPPORT AT 25ML/HOUR". SEE ATTACHED USER FACILITY REPORT #1402330000-2005-8004.

    Description of Event or Problem · 1

    THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT REPORTED A PT DEATH HAD OCCURRED WHILE A COLLEAGUE INFUSION PUMP WAS CONNECTED TO A PT. THE PUMP WAS INFUSING 200MG DOPAMINE HCL IN 250ML OF 5% DEXTROSE TO A "TRAUMA PT". DOPAMINE INFUSION WAS PROGRAMMED AT A RATE OF 15ML/HR WITH A VOLUME TO BE INFUSED OF 250ML. DURING THE INFUSION, THE RATE WAS REPORTED TO BE INCREASED TO 25ML/HR AND THEN TO A RATE OF 50ML/HR. THE PT WAS BEING TRANSPORTED TO THE OPERATING ROOM WITHIN THE HOSP AND REPORTEDLY, SHORTLY AFTER THE PUMP WAS UNPLUGGED FOR THE PT MOVE, THE PUMP DISPLAYED 570 FAILURE CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE PTE. LTD. COLLEAGUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death