BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 3820152 · Received May 20, 2014

    Report

    Report Number
    1226348-2014-11646
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 19, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    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, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CNGCMM, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3842, AND NOT 82-3146 AS FIRST NOTED IN ETQ. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS VISUALLY INSPECTED, NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST, DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. 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 VALVE WAS DRIED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED; THE VALVE PASSED THE TEST. THE VALVE WAS RETESTED FOR PROGRAMMING; THE VALVE FAILED THE TEST, DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS THEN PRESSURE TESTED AT 70MMH2O, 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, AND ON THE BASE PLATE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. THE ROOT CAUSE FOR 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. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED; ACCORDING TO SURGEON, SHUNT PRESSURE AT 70 MMH20 WAS CHANGED TO 90 MMH20 BUT STILL OVER-DRAINAGE WAS OCCURRING AS PER SURGEON, SHUNT WAS NOT PERFORMING AS EXPECTED AS PATIENT WAS GETTING FREQUENT HEADACHES HENCE HE REPLACED THE SAME AND NOW HE WANTS US TO EXAMINE THE SHUNT AND LET HIM KNOW OF THE OUTCOME. AFTER PROGRAMMING SHUNT NOT PERFORMING AS PER SETTING DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299156 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CNGCMM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention