BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4357781 · Received December 23, 2014

    Report

    Report Number
    1226348-2014-12155
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 3, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION THE VALVE WAS VISUALLY INSPECTED AND THE VALVE WAS NOT CORRECTLY ASSEMBLED. THE VALVE MECHANISM WAS ASSEMBLED IN REVERSE IN ITS HOUSING. THIS DEFECT EXPLAINS THE DRAINAGE PROBLEM OBSERVED BY THE CUSTOMER. THE VALVE WAS IRRIGATED WITH PURIFIED WATER, IN THE DIRECTION OF THE ARROW, THE FLOW WAS ABNORMALLY SLOW. THE VALVE WAS ALSO IRRIGATED WITH PURIFIED WATER IN THE OTHER DIRECTION, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED IN THE DIRECTION OF THE ARROW, THE VALVE PASSED. THE VALVE WAS REFLUX TESTED IN THE OTHER DIRECTION, THE VALVE PASSED. THE VALVE WAS PROGRAM TESTED THE VALVE FAILED THE TEST, THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS PRESSURE TESTED AT 150MMH2O IN THE DIRECTION OF ARROW, THE VALVE FAILED 186MMH2O. THE VALVE WAS PRESSURE TESTED AT 150MMH2O IN THE OTHER DIRECTION, THE VALVE PASSED. NO STOCK AUDIT WAS PERFORMED AS NO PRODUCT FROM THIS LOT REMAINED IN OUR STOCK. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3114, WITH LOT CLPBDH, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 22ND DECEMBER 2010. THE INVESTIGATION OF THE RETURNED VALVE CONFIRMED THE DEFECT: THE VALVE WAS NOT CORRECTLY ASSEMBLED. THE ROOT CAUSE OF THE PROBLEM REPORTED IS DUE TO HUMAN ERROR. BASED ON THE RESULTS OF THIS INVESTIGATION ACTION WILL BE TAKEN TO PREVENT EVENTS LIKE THIS FROM HAPPENING IN THE FUTURE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE VALVE DOESN´T DRAIN CORRECTLY. NO OTHER INFORMATION AVAILABLE AT THE PRESENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846781 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CLPBDH

    Patients

    Seq Age Sex Outcome Treatment
    1