BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD

    MDR report key: 4146676 · Received October 7, 2014

    Report

    Report Number
    1226348-2014-12032
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 26, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. DEVICE IS UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 150MMH2O. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. 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, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED. NO LEAKAGE WAS NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE FAILED THE TEST, THE CAM MECHANISM WAS BLOCKED AT 100MMH20. THE VALVE WAS DISMANTLED, BIOLOGICAL DEBRIS WERE NOTED ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, ON THE SPRING, ON THE SPRING PILLAR AND ON THE BASE PLATE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE 82-3852, LOT NUMBER CPFCFM, WAS CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 4TH JUNE, 2013. THE ROOT CAUSE FOR THE PROBLEMS FOUND DURING INVESTIGATION IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, ON THE SPRING, ON THE CAM MECHANISM ON THE BASE PLATE AND ON THE CAM MECHANISM PILLAR. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED 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

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT SHE HAS A SURGEON WHO WOULD LIKE AN EXPLANTED VALVE EVALUATED. HE DOESN'T THINK THE VALVE WAS THE PROBLEM, BUT WANTS TO SEE IF AN EVALUATION FINDS OTHERWISE. SURGEON DOES NOT THINK THE VALVE WAS THE ISSUE AS IT WAS PATIENT INTRA-OPERATIVELY, BUT HE WOULD LIKE THE EXPLANTED VALVE EVALUATED. THE SURGERY WAS NOT DELAYED MORE THAN 30 MINUTES. E-MAIL RECEIVED FROM THE SALES REP. ON (B)(6) 2014, INFORMED THAT THE PATIENT WAS IN A COMA BEFORE SURGERY AND STILL IS TO HER KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628349 PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPFCFM

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention