BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3222054 · Received July 3, 2013

    Report

    Report Number
    2016493-2013-00300
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED BROKEN BEZEL WAS CONFIRMED. THE DEFECTS OBSERVED INCLUDED CRACKS, FRACTURES, OR SEPARATIONS OR A COMBINATION OF THESE DEFECTS. THE BEZEL DATE CODE WAS 10/11 (OCTOBER 2011). THE DOOR ON THIS DEVICE COULD BE CLOSED PROPERLY WITH THE BEZEL DAMAGE; THEREFORE, NO UNREGULATED FLOW CONDITION WOULD OCCUR FROM THE BEZEL DAMAGE. THE ROOT CAUSE OF THIS FAILURE HAS NOT BEEN DETERMINED. DAMAGE WAS ALSO PRESENT ON THE REAR CASE, THE MEMBRANE FROM WAS BROKEN AND THE PLATEN WAS MISSING. THE MISSING PLATEN WOULD RESULT IN AN UNREGULATED FLOW CONDITION. THE ROOT CAUSE OF THE MISSING PLATEN CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    CAREFUSION FIELD SERVICE TEAM IDENTIFIED A CRACK IN THE DEVICE BEZEL AND DEVICE WAS RETURNED TO CAREFUSION FOR REPAIR. NO PT INCIDENT WAS REPORTED WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304676 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNK| ALARIS PC UNIT, SN UNK