BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM VALVE

    MDR report key: 6141724 · Received December 2, 2016

    Report

    Report Number
    1226348-2016-10837
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 15, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    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 IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE SIPHON GUARD WAS TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE NS9008 WITH LOT CVDCPG, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 20TH APRIL 2016. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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

    BEFORE IMPLANTING, IT WAS CONFIRMED WATER DID NOT FLOW FROM DISTAL SIDE WHEN THE SURGEON PERFORMED PUMPING THE VALVE TO TEST WATER FLOW AFTER PASSING WATER TO THE VALVE AND CATHETER. THE SURGEON PUMPED THE VALVE AROUND 40 TIMES AND SUCTIONED IT WITH A SYRINGE FROM DISTAL SIDE FOR ABOUT 30 MINUTES, BUT WATER DID NOT FLOW. THIS SURGERY WAS COMPLETED BY USING ANOTHER VALVE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT AND NO INFORMATION WAS PROVIDED BY HOSPITAL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791437 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVDCPG

    Patients

    Seq Age Sex Outcome Treatment
    1