BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE INFUSION SET

    MDR report key: 3961122 · Received July 23, 2014

    Report

    Report Number
    MW5037437
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 22, 2014
    Manufacturer
    CARE FUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRIMARY INFUSION TUBING BLEW UP LIKE A BALLOON IN THE SECTION THAT IS IN THE ALARIS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432192 SMARTSITE INFUSION SET PRIMARY IV TUBING FPA CARE FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR