BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1013168 · Received March 14, 2008

    Report

    Report Number
    6000001-2008-00160
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 12, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE, LTD
    Product Code
    FRN
    Removal / Correction Number
    FCA#2007-0056-MD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY INDICATED THAT THE PT SAFETY AND QUALITY TEAM ARE CURRENTLY PERFORMING AN INTERNAL INVESTIGATION. A COPY OF THE EVENT HISTORY WILL BE PROVIDED TO BAXTER. A REQUEST WAS MADE FOR RETURN OF THE DEVICE TO THE PRODUCT ANALYSIS LAB FOR EVALUATION. THE FACILITY INDICATED THAT THE DEVICE WOULD NOT RELEASED TO BAXTER UNTIL THEIR PT SAFETY AND QUALITY GROUP HAD COMPLETED THEIR EVAL. THIS ISSUE IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 1

    INITIALLY, THE CUSTOMER CONTACTED THE BAXTER SALES REPRESENTATIVE TO REPORT THAT ALL THREE CHANNELS ON A COLLEAGUE VOLUMETRIC INFUSION PUMP SHUT DOWN DURING PATIENT INFUSION OF CRITICAL (UNKNOWN) MEDICATIONS RESULTING IN INTERRUPTION OF THERAPY. THE FACILITY REPORTED THAT THE PUMP SHUT DOWN, THE PT DIED, AND THE DEATH WAS DUE TO THE PUMP SHUTTING DOWN DURING PT USE. AS PER THE RECOMMENDATION OF REGIONAL HEALTH AUTHORITY, TWO (2) PUMP CHANNELS WERE ON CLOSE MODE AND THE THIRD CHANNEL WAS A REGULAR INFUSION NOT USING THE DOSE MODE. THE INCIDENT OCCURRED IN THE HEALTH SCIENCES CENTRE, WHERE THE COLLEAGUE PUMP WAS BEING USED TO DELIVER MEDICATIONS TO A CRITICALLY ILL PT IN THE CRITICAL CARE UNIT. THE FACILITY CONFIRMED THAT THE FAILURE CODE OBSERVED WAS 16:310.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3 CXE VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death