BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 5363442 · Received January 13, 2016

    Report

    Report Number
    1226348-2016-10049
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    October 6, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 120MMH2O. THE VALVE WAS VISUALLY INSPECTED: A SMALL HOLE WAS NOTED IN THE SILICONE HOUSING ON THE SIDE OF THE VALVE (POSSIBLE NEEDLE HOLE). THE VALVE WAS IRRIGATED WITH PURIFIED WATER. AN OCCLUSION WAS NOTED AT THE INLET OF THE RUBY BALL. THEREFORE A FINE NEEDLE WAS INSERTED INTO THE FLOW OPENING OF THE VALVE INLET UNDER THE RUBY BALL AND ITS SEAT, THE RUBY BALL WAS MANUALLY POPPED FREE FROM ITS STUCK POSITION USING LIGHT FORCE. THE VALVE WAS IRRIGATED AGAIN, NO OCCLUSION WAS NOTED. THE CATHETER WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED, THE VALVE LEAKED FROM THE SMALL HOLE IN SILICONE HOUSING. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE FAILED THE TEST, DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS THEN PRESSURE TESTED AT 120MMH2O, THE VALVE FAILED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. THE CAM MAGNETS WERE ALSO CONTROLLED. THE MAGNETS PASSED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3115 WITH LOT CRNCCL, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 9TH JANUARY 2015. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, AND ON THE BASE PLATE. THE ROOT CAUSE TO THE SMALL HOLE IN THE SILICONE HOUSING COULD BE DUE TO A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE SILICONE, THIS HOWEVER COULD NOT BE DETERMINED. 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

    THE VALVE IS LIKELY TO BE JAMMED DUE TO BLEEDING DURING SHUNT OPERATION. ON (B)(6) 2016: PER AFFILIATE: WAS THERE ANY PATIENT INJURY? NO. WAS THERE A DELAY IN SURGERY OVER 30 MINUTES? NO. IS THERE A LOT OR SERIAL NUMBER THAT YOU CAN PROVIDE? NO. WHAT ACTIONS WERE TAKEN AS A RESULT OF THE INCIDENT? NO. ON (B)(6) 2016 PER AFFILIATE: IT HAS BEEN REPLACED WITH ANOTHER AND THE BLOCKED VALVE WILL BE SENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21892 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CRNCCL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention