BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 543243 · Received September 8, 2004

    Report

    Report Number
    6000001-2004-01414
    Event Type
    Death
    Date Received
    September 8, 2004
    Date of Event
    July 28, 2004
    Report Date
    August 9, 2004
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED THAT AN INFUSION PUMP "WAS OPERATING ON BATTERY POWER WHEN IT ALARMED SEVERAL TIMES AND THEN SHUT DOWN WITHOUT WARNING" AT THE FACILITY. THE PUMP WAS INFUSING "QUADRUPLE STRENGTH" INOTROPIC DRUGS TO A CRITICALLY ILL PT WHEN THE EVENT OCCURRED. THE STAFF QUICKLY LOCATED ANOTHER PUMP AND THE INFUSIONS WERE RESUMED. THE PT WAS REPORTED TO EXPIRE; HOWEVER, THE HOSP BELIEVES THE PUMP "WAS NOT AT FAULT." DESPITE BAXTER'S EFFORTS TO OBTAIN ADDITIONAL INFO FROM THE REPORTING FACILITY, DETAILS WERE NOT AVAILABLE REGARDING PT'S DEMOGRAPHICS, DIAGNOSIS AND MEDICAL HISTORY, NAME OF INOTROPIC DRUGS INVOLVED, CAUSE OF THE PT'S DEATH, AUTOPSY RESULTS, 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 UNKNOWN Death