BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4541816 · Received February 24, 2015

    Report

    Report Number
    1226348-2015-10110
    Event Type
    Injury
    Date Received
    February 24, 2015
    Date of Event
    February 9, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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 70MMH2O. THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED IN THE SILICONE HOUSING BEFORE THE VALVE MECHANISM. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE CATHETER WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED. 24, A SMALL LEAK WAS NOTED IN THE SILICONE HOUSING BETWEEN THE VALVE MECHANISM AND THE DISTAL CONNECTOR; THIS COULD BE A NEEDLE HOLE. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED. 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, AND ON THE BASE PLATE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3115, WITH LOT CRFBGL, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 25TH MAY 2014. THE ROOT CAUSE OF THE PRESSURE PROBLEM IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE BASE PLATE. THE ROOT CAUSE OF THE SMALL HOLE IN THE SILICONE HOUSING BETWEEN THE VALVE MECHANISM AND THE DISTAL CONNECTOR COULD BE DUE TO A NEEDLE, BUT THIS 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

    THERE WAS A SYMPTOM WHICH IMPLIED THE BLOCKAGE OF PERITONEAL CATHETER SO THEY OPENED THE PART AND FOUND OUT THAT THERE WAS NO PROBLEM. THUS, THEY CHECKED THE SHUNT AND FINALLY DETECTED THAT IT HAD BEEN CLOGGED WITH BIOLOGICAL DEBRIS, SO IT HAS BEEN REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128352 HAKIM PROGRAMMABLE VALVE NERVOUS SYSTEM & COMPONENTS JXG CODMAN & SHURTLEFF, INC. CRFBGL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention