BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OUTLOOK 400ES LARGE VOLUME INFUSION PUMP

    MDR report key: 2182292 · Received July 22, 2011

    Report

    Report Number
    MW5021493
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 22, 2011
    Manufacturer
    B BRAUN MEDICAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BBRAUN PUMP, SERIAL # (B)(4). IV FLUIDS INFUSING THROUGH BBRAUN PUMP INTO PERIPHERAL IV OF A (B)(6) WEEK INFANT. VOLUME TO BE INFUSED NEVER DECREASED OVER AN HOUR. WHEN CHECKING THE PUMP TO DETERMINE THE AMOUNT INFUSED, THE PUMP WOULD NOT POWER OFF, PLACE ON HOLD, OR DISPLAY MENU. THE PUMP SHOWED THAT THE PUMP WAS STILL RUNNING EVEN WHEN THE IV TUBING WAS REMOVED. WE WERE UNSURE OF THE AMOUNT THE INFANT RECEIVED. THIS WAS THE INFANT'S ONLY NUTRITION AND IV FLUIDS RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK 400ES LARGE VOLUME INFUSION PUMP INFUSION PUMP FRN B BRAUN MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening