BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE 10 VALVE

    MDR report key: 18248536 · Received December 1, 2023

    Report

    Report Number
    3004721439-2023-00358
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 22, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906504410
    PMA / PMN Number
    K192266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE INVESTIGATION, NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVES WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE M.BLUE IS PERMEABLE. DURING THE PERMEABILITY TEST BLOODY LIQUID WERE FLUSHED OUT. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF OVER- DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE VALVE IS TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE M.BLUE OPERATES NOT WITHIN THE ACCEPTED TOLERANCE IN BOTH POSITIONS. AN ACCELERATED OUTFLOW OF M.BLUE COULD BE DETERMINED. ADJUSTMENT TEST: THE M. BLUE VALVE WAS TESTED AND IS ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVE, DEPOSITS WERE FOUND IN M.BLUE. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE AN ACCELERATED OUTFLOW IN THE VALVE. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE FUNCTIONAL DEVIATION. PROTEINS IN THE CEREBROSPINAL FLUID CAN INFLUENCE THE FUNCTION TEMPORARILY AND ARE KNOWN SIDE EFFECTS IN HYDROCEPHALUS THERAPY. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE VALVE MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG. NO FURTHER REGULATORY ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    IMPLANTATION: (B)(6) 2019 EXPLANTATION: (B)(6) 2023. FILE ENTERED WITH LIMITED INFORMATION: DELIVERED IN RETURN KIT IN UNKNOWN LIQUID. AGE Y: 4 / WEIGHT KG: 17.6 / HEIGH CM: 106 / GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539300 M.BLUE 10 VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX802T 20042004 04041906504410

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Required Intervention