BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS, SMARTSITE

    MDR report key: 6408938 · Received March 16, 2017

    Report

    Report Number
    6408938
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    January 28, 2017
    Report Date
    March 14, 2017
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    J-LOOPS ARE FREQUENTLY NOT FLUSHING. IV FLUSHES WITH JUST END CAP IN PLACE BUT IF J-LOOP IS ATTACHED THE IV WILL NOT FLUSH AND PUMP WILL NOT RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191991 ALARIS, SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 303, INC. 20021E 16125282

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR