BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 622334 · Received July 22, 2005

    Report

    Report Number
    6000001-2005-02893
    Event Type
    Death
    Date Received
    July 22, 2005
    Date of Event
    July 2, 2005
    Report Date
    July 6, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BAXTER REPORTED AN INFUSION PUMP THAT FAILED DURING A PT'S TRANSFER. THE PT EXPIRED. THE PUMP WAS REPORTED TO BE INFUSING UNSPECIFIED CARDIAC MEDICATIONS VIA THREE CHANNELS DURING THE TRANSFER. THE PT WAS BEING TRANSFERRED VIA AMBULANCE FROM A HOSP TO ANOTHER HOSP, WHICH WAS APPROX 17 MILES AWAY. THE PT WAS ACCOMPANIED BY A NURSE. REPORTEDLY, THE NURSE CHECKED THE BATTERY LEVEL PRIOR TO THE TRANSFER AND THE LEVEL WAS "FINE". DURING THE TRANSPORT, THE PUMP EXPERIENCED A LOW BATTERY ALERT AFTER APPROX 30 MINUTES OF BATTERY USE. THE PUMP SUBSEQUENTLY SHUT DOWN AND THE PT EXPIRED DURING THE TRANSFER. DESPITE BAXTER'S EFFORT TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTING FACILITY'S NURSE EDUCATOR, DETAILS WERE NOT AVAILABLE REGARDING WHETHER OR NOT AN AUTOPSY WAS PERFORMED, CAUSE OF THE PT'S DEATH, AUTOPSY REPORT. PT'S DEMOGRAPHICS, DIAGNOSIS AND MEDICAL HISTORY, REASON FOR THE PT'S TRANSPORT, NAMES, RATES, AND CONCENTRATIONS OF MEDICATIONS INVOLVED, MEDICAL INTERVENTION IMPLEMENTED, AND 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 PTE. LTD. COLLEAGUE 3CX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death