BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHPV CYL W/RR UN120CM DIST

    MDR report key: 5612129 · Received April 27, 2016

    Report

    Report Number
    1226348-2016-10320
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    March 23, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK122118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED FOR ABOUT 44 HOURS. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4) AND PROGRAMMER 82-3190 WITH SERIAL NUMBER (B)(4) , THE VALVE FAILED THE TEST, THE CAM MECHANISM DID NOT MOVE DURING THE PROGRAMMING PROCESS. THE VALVE WAS FLUSHED. THE VALVE PASSED THE TEST. THE CATHETER WAS IRRIGATED, NO OCCLUSION WAS NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS LEAK TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS PRESSURE TESTED AT 70MMH2O, THE VALVE PASSED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE CAM MECHANISM. THE CAM MAGNETS WERE ALSO CONTROLLED. THE MAGNETS PASSED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3851, WITH LOT CTPBC4, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 8TH JANUARY 2016. THE ROOT CAUSE OF THE PROBLEM IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE RUBY BALL, AND ON THE CAM MECHANISM. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    OPENING PX TESTED WITH MANOMETER ON THE BACK TABLE AND SURGEON FELT THERE WAS TOO MUCH DISCREPANCY AS COMPARED TO DESIRED /PROGRAMMED SETTING. NO DELAY IN CASE. OPENED ANOTHER CHPV WHICH WORKED AS INTENDED. I HAVE THE PART TO RETURN. ON 4/8/2016 PER REP, NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268543 CHPV CYL W/RR UN120CM DIST PRECISION FIXED PRESSURE VALVE JXG CODMAN & SHURTLEFF, INC. CTPBC4

    Patients

    Seq Age Sex Outcome Treatment
    1