BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3062679 · Received March 13, 2013

    Report

    Report Number
    3062679
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 13, 2013
    Manufacturer
    CAREFUSION 303,INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NURSES NOTICED THAT THE VANCOMYCIN, WHICH WAS HUNG AS A SECONDARY BAG, WAS INFUSING TOO FAST. IT WAS INFUSING FASTER THAN THE SET RATE ON THE PUMP. FURTHERMORE, IT CONTINUED TO INFUSE AFTER THE PUMP WAS TURNED OFF. ANOTHER PUMP AND TUBING WAS OBTAINED AND THE PUMP AND TUBING WERE SEQUESTERED AND SENT TO BIOMED. BIOMED CONFIRMED IT WAS A BACK-CHECK VALVE FAILURE ON THE TUBING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106243 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303,INC. * 13025253

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR