BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 4548302 · Received February 26, 2015

    Report

    Report Number
    1226348-2015-10123
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 11, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 140MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER: NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED. NO LEAKS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. 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 82-3162, WITH LOT CRHBZ6, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 10TH AUGUST 2015. NO ROOT CAUSE COULD BE DETERMINED FOR THE PROBLEM REPORTED BY THE CUSTOMER, AS THE VALVE FUNCTIONED. THE PROBLEM WAS LIKELY DUE TO AN EXCESSIVE FLOW RATE (>0.75 ML/MIN) DURING THE FLUSHING PROCEDURE ACTIVATES THE SIPHON GUARD AND CREATES THE IMPRESSION THAT THE VALVE IS DISTALLY OCCLUDED. IN REALITY THE FLOW IS BEING DIVERTED TO THE HIGH RESISTANCE SECONDARY PATHWAY, THIS WILL SLOW THE RATE AT WHICH CSF IS SHUNTED FROM THE BRAIN. IT WOULD PROBABLY EXPLAIN THE PROBLEM ENCOUNTERED BY THE CUSTOMER. 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

    VALVE DIDN¿T FLUSH. ON (B)(6) 2015 PER REP: PLEASE SUPPLY THE ALERT DATE. (B)(6) 2015. WERE THERE ANY ADVERSE CONSEQUENCES TO THE PATIENT? NO. WHAT ACTIONS WERE TAKEN AS A RESULT OF THIS INCIDENT? THEY OPENED UP ANOTHER VALVE AND EVERYTHING WENT SMOOTH ONE WITHOUT SIPHON GUARD. IS THERE A SERIAL OR LOT NUMBER YOU CAN PROVIDE? LOT CRHBZ6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136903 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CRHBZ6

    Patients

    Seq Age Sex Outcome Treatment
    1