BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC PUMP

    MDR report key: 2103395 · Received May 20, 2011

    Report

    Report Number
    MW5020706
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 20, 2011
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS GETTING INOTROPIC INFUSION AFTER CARDIAC SURGERY USING ALARIS PUMP. AFTER 2 HOURS OF NORMAL OPERATION, THE PUMP SUDDENLY STOPPED FUNCTIONING W/ "COMMUNICATION ERROR" MESSAGE DISPLAYED. RESET THE PUMP BUT THIS OCCURRED AGAIN AFTER ANOTHER 5 MINUTES OF NORMAL OPERATION. TOOK PUMP OUT OF SERVICE AND REPLACED IT WITH ANOTHER ALARIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC PUMP SMART PUMP FRN CAREFUSION 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR