BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1X2 CDP PM KIT

    MDR report key: 2141736 · Received June 27, 2011

    Report

    Report Number
    2015691-2011-15790
    Event Type
    Malfunction
    Date Received
    June 27, 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

    RECEIVED ONE CUSTOM PRESSURE MONITORING KIT, MODEL PXMK1861. THE CDP KIT INCLUDED A BIFURCATED IV SET WITH ATTACHED MERIT FLUSH DEVICE AND PRESSURE TUBING. PRIMING SOLUTION WAS VISIBLE THROUGHOUT THE KIT. THE COMPLAINT OF "PRESSURE LINE AND FLUSH LINE SEEMED TO BE INTERCHANGED" WAS CONFIRMED. THE KIT CONTAINED THE CORRECT COMPONENTS BUT IT WAS NOT BUILD CORRECTLY. THE PRESSURE TUBING AND IV EXTENSION TUBING WERE CONNECTED TO THE INCORRECT LUERS OF THE Y-ADAPTOR. THE IV EXTENSION TUBE SHOULD CONNECT TO MERIT FLUSH DEVICE. THUS THE IV SOLUTION FLOW THROUGH EITHER THE PRESSURE TUBING OR THE 3-WAY STOPCOCK COULD BE CONTROLLED BY THE FLUSH DEVICE. DUE TO INCORRECT ASSEMBLY, IV SOLUTION THROUGH THE STOPCOCK CANNOT BE CONTROLLED BY THE MERIT FLUSH DEVICE. THE INCORRECT ASSEMBLY CONFIGURATION WAS OBSERVED ON BOTH IV LINES. THE INCORRECT ASSEMBLY WAS CONFIRMED TO BE A MANUFACTURING DEFECT. AN INVESTIGATION WAS OPENED AND ACTIONS ARE BEING IMPLEMENTED TO PREVENT RECURRENCE OF A 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

    IT WAS REPORTED THAT THE NURSE OPENED THE UNIT, PRIMED IT AND HOOKED IT UP TO THE PATIENT'S PA CATHETER. IMMEDIATELY AFTER HOOK-UP, THE NURSE COULD SEE IN THE DRIP CHAMBER THAT THE FLUID RAN NOT ONLY WHEN THE FLUSH TAB WAS PULLED; IT RAN CONTINUOUSLY. THE NURSE TURNED OFF THE LINE AND ASKED FOR ANOTHER SET-UP. THE NURSE REMARKED THAT THE UNIT DID NOT LOOK RIGHT TO HER; SHE NOTED THAT THE PRESSURE LINE AND FLUSH LINE SEEMED TO BE INTERCHANGED. 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