BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER

    MDR report key: 4018085 · Received August 18, 2014

    Report

    Report Number
    1226348-2014-11908
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 4, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    (B)(4). IT WAS NOTED THAT THE PRODUCT CODE IS 82-3110 AND NOT 82-3832 AS PREVIOUSLY REPORTED. THE LOT NUMBER IS CPDBH0 AND NOT CPGCJ5 AS PREVIOUSLY REPORTED. IT HAS BEEN COMMUNICATED THAT THE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. 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 CATHETERS WERE IRRIGATED WITH PURIFIED WATER, 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 TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3110, WITH LOT NUMBER CPDBH0, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 16TH MAY 2013. NO ROOT CAUSE COULD BE DETERMINED, AS NO PROBLEM WAS FOUND WITH THE VALVE.

    Additional Manufacturer Narrative · 1

    AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE PATIENT IS FEMALE AND (B)(6), DID V-P PROCEDURE ON (B)(6) 2014. HIGH FRICTION WAS FOUND DURING THE VALVE PRE-PERFUSION. THE DEVICE WAS NOT USED ON THE PATIENT. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT ON THE PATIENT. IT WAS NOTED THAT THE PROBLEM WAS DETECTED BEFORE USE ON THE PATIENT. QUESTIONS: WHAT IS MEANT WHEN YOU SAY ¿HIGH FRICTION¿ WAS FOUND DURING THE PRE-PERFUSION¿ - IT MEANS THAT THE LIQUID IS DIFFICULT TO FLOW THROUGH THE VALVE. DID THIS CAUSE A DELAY GREATER THAN 30 MINUTES AS A RESULT OF HAVING TO CHANGE THE DEVICE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494859 HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPDBH0

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR