BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV CYL W/LG RR NU120CM DIST

    MDR report key: 4532221 · Received February 20, 2015

    Report

    Report Number
    1226348-2015-10098
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    January 26, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK122118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. 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 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 30MMH2O, THE VALVE PASSED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING PILLAR, 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 WERE OK. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING PILLAR, 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. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3852, WITH LOT CRDCN2, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 7TH MAY 2014. 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.

    Description of Event or Problem · 1

    CAN YOU PLEASE ASSIGN A COMPLAINT TO AN EXPLANT THAT OCCURRED ON (B)(6). THE VALVE ITEM 823852 WAS EXPLANTED DUE TO UNKNOWN MALFUNCTION. THE VALVE WAS ORIGINALLY IMPLANTED IN (B)(6). THE SURGEON HAS REQUESTED THAT THE ITEM BE INVESTIGATED TO DETERMINE WHAT WAS THE SPECIFIC MALFUNCTION. (B)(4) 2015 PER REP: THE ALERT DATE: (B)(6) 2015. THE LOT / SERIAL NUMBERS- UNKNOWN. THE YEAR OF THE IMPLANT: (B)(6) 2014. A DESCRIPTION OF THE EVENT. THE VALVE WOULD NOT REPROGRAM THEREFORE IT WAS EXPLANTED. WERE THERE ANY CONSEQUENCES TO THE PATIENT? NO. WHAT ACTIONS WERE TAKEN AS A RESULT OF THIS INCIDENT? EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121925 CHPV CYL W/LG RR NU120CM DIST PRECISION FIXED PRESSURE VALVE JXG CODMAN & SHURTLEFF, INC. CRDCN2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention