BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE

    MDR report key: 3834517 · Received May 27, 2014

    Report

    Report Number
    3834517
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    ON FOUR SEPARATE OCCASIONS OVER THE LAST TWO WEEKS NURSING STAFF IN THE ONCOLOGY DEPARTMENT HAVE REPORTED THAT PIGGY-BACKED SOLUTIONS HAVE BACKED UP INTO THE PRIMARY SOLUTION EVEN THOUGH CHECK VALVES IN THE CIRCUIT SHOULD HAVE STOPPED THIS FROM HAPPENING.MANUFACTURER RESPONSE FOR IV INFUSION SET, ALARIS (PER SITE REPORTER).====================== THE MANUFACTURER PLANS TO INVESTIGATE BUT INDICATES THAT THIS HAS BEEN KNOWN TO OCCUR WHEN PARTICULATE MATTER GETS STUCK IN THE CHECK VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310872 ALARIS SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION * 14045075

    Patients

    Seq Age Sex Outcome Treatment
    1 *