BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE ADMINISTRATION SET

    MDR report key: 2233140 · Received July 20, 2011

    Report

    Report Number
    9616066-2011-00411
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K931550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN REC'D FOR INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN REC'D AND AN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT DURING AN INFUSION, THE PUMP ALARMED FOR AIR IN LINE TWICE AND AFTER RECONNECTING THE SET, THEY NOTICED A LEAK FROM A CRACK OF APPROX 5 MM IN THE ACCUSLIDE. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE ADMINISTRATION SET FPA CAREFUSION CORPORATION 72303 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS SE PUMP, SN UNK