BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 5477772 · Received March 3, 2016

    Report

    Report Number
    1226348-2016-10174
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    February 12, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 120MMH2O. 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, ONLY LEAKED FROM THE NEEDLE HOLES IN THE NEEDLE CHAMBER. 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 CTLBBN, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 6TH OCTOBER 2015. NO ROOT CAUSE COULD BE DETERMINED AS THE PROBLEM REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. 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, THIS HOWEVER COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE VALVE WAS BLOCKED OUT OF THE PACKAGE - WOULD NOT PUMP FLUID DISTALLY. THERE WAS A BACKUP VALVE AVAILABLE. NO PATIENT HARM OR DELAY IN SURGERY AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132467 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTLBBN

    Patients

    Seq Age Sex Outcome Treatment
    1