BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 378341 · Received February 22, 2002

    Report

    Report Number
    6000001-2002-00075
    Event Type
    Death
    Date Received
    February 22, 2002
    Date of Event
    January 1, 2002
    Report Date
    January 24, 2002
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PUMP REPORTED TO HAVE SHUT DOWN WITHOUT ALARMING ON A PATIENT RECEIVING AN ADRENALINE INFUSION (DOUBLE OR TRIPLE STRENGTH 12 OR 18MG/100ML AT A RATE OF 40ML/HR). THE CLINICIAN LOOKING AFTER THE PATIENT VERIFIED THAT PUMP WAS RUNNING NORMALLY WHEN HE LEFT THE PATIENT. REPORTEDLY, AFTER A COUPLE MINUTES THE CLINICIAN WAS CALLED BACK TO THE PATIENT IN RESPONSE TO THE PATIENT'S BLOOD PRESSURE ALARM. AT THIS TIME THE CLINICIAN NOTED THE PUMP WAS OFF. PRIOR TO THE REPORTED PUMP INCIDENT THE PHYSICIAN AND THE NUM (NURSE UNIT MANAGER) WERE DEBATING WHETHER TO CONTINUE THERAPY. AFTER THE INCIDENT, THE STAFF CLINICIAN MADE THE DECISION TO DISCONTINUE THERAPY AND THE PATIENT SUBSEQUENTLY DIED. REPORTEDLY, THE PHYSICIAN INVOLVED CONFIRMED THAT THE PUMP DID NOT DIRECTLY CAUSE THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP COLLEAGUE VOLUMETRIC PUMP FRN BAXTER HEALTHCARE (SG) COLLEAGUE 3CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death