BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE

    MDR report key: 1061882 · Received June 17, 2008

    Report

    Report Number
    MW5007350
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 17, 2008
    Manufacturer
    MEDEX
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLOOD NOTED TO BE BACKING UP THROUGH IV LINE. CONNECTIONS CHECKED AND LINE FLUSHED. FLUID NOTED TO BE LEAKING FROM CENTER OF FILTER. DEVICE REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXT SET 0.2 MIC. FILTER VALVE PV=3.1ML FPA MEDEX SM5020 1275324

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA