BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMART SITE VALVE

    MDR report key: 2211457 · Received August 9, 2011

    Report

    Report Number
    MW5021714
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CAREFUSION
    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

    PRIOR TO HANGING IV FLUIDS, RN NOTED FILTER TUBING WITH MEDICATION PORT POINTING UP TOWARD THE FILTER. INFUSION SET DISCARDED, NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SMART SITE VALVE IV FILTER TUBING FPA CAREFUSION 1839589

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other