BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1X2 CDP PM KIT

    MDR report key: 2143213 · Received June 28, 2011

    Report

    Report Number
    2015691-2011-15797
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 7, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNITS WERE NOT RETURNED FOR EVALUATION. THEREFORE THE INCORRECT ASSEMBLY COULD NOT BE CONFIRMED. HOWEVER THE ISSUE WAS CONFIRMED ON ANOTHER COMPLAINT UNIT THAT WAS RETURNED. AN INVESTIGATION WAS OPENED AND ACTIONS ARE BEING IMPLEMENTED TO PREVENT RECURRENCE OF COMPLAINT OF THIS TYPE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    AFTER HAVING DIFFICULTY WITH A PRESSURE TRANSDUCER, THREE ADDITIONAL UNITS WERE PRIMED AND FOUND TO HAVE THE SAME PROBLEM. THE PRESSURE TRANSDUCERS ALLOWED THE FLUID TO RUN NOT ONLY WHEN THE FLUSH TAB WAS PULLED; THE FLUID RAN CONTINUOUSLY. THE NURSE REMARKED THAT THE UNITS DID NOT LOOK RIGHT TO HER; SHE NOTED THAT THE PRESSURE LINES AND FLUSH LINES SEEMED TO BE INTERCHANGED. THEY BELIEVE THEY ARE ALL THE SAME LOT NUMBER. THE UNITS WERE NOT USED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1X2 CDP PM KIT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PXMK1861 59033657

    Patients

    Seq Age Sex Outcome Treatment
    1