BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE PLUS VALVE

    MDR report key: 16668657 · Received April 3, 2023

    Report

    Report Number
    3004721439-2023-00071
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    September 9, 2022
    Report Date
    April 3, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906504793
    PMA / PMN Number
    K192266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: SCRATCHES ON THE OUTER HOUSING OF THE M.BLUE AND BLOODY RESIDUES ON THE PROGAV 2.0. PERMEABILITY TEST: THE TEST SHOWED THAT THE M.BLUE AND THE PROGAV 2.0 ARE PERMEABLE. COMPUTER CONTROL TEST: TO CHECK THE FLOW RATE OF THE VALVES,THE VALVES WERE TESTED ON A MIETHKE COMPUTER- CONTROLLED TESTING APPARATUS AND PASSED THE STANDARD TEST. THE FLOW OF THE TEST LIQUID WAS REDUCED STEP BY STEP FROM 60 ML/H TO 5 ML/H (IN ACCORDANCE WITH ISO 7197). DISTILLED WATER WAS USED AS THE TEST-LIQUID. THE RESULTING PRESSURE WAS MEASURED. THE COMPUTER CONTROLLED TEST SHOWED THE OPENING PRESSURE OF THE DIFFERENTIAL UNIT OF THE M.BLUE®, AT A REFERENCE FLOW RATE OF 20 ML/H IN A HORIZONTAL POSITION OF THE VALVE, TO BE 1,92 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 0 - 4 CMH2O. ADDITIONALLY, THE GRAVITATIONAL UNIT OF THE M.BLUE WAS TESTED ACCORDING TO STANDARD PROCEDURE IN THE VERTICAL POSITION OF THE VALVE. AT AN OPENING PRESSURE OF 33 CMH2O IN THE VERTICAL POSITION, A PRESSURE OF 33 CMH2O ± 8 CMH2O IS EXPECTED. THE RESULTS INDICATED THAT AT A REFERENCE FLOW OF 20 ML/H IN THE VERTICAL POSITION, THE GRAVITATIONAL UNIT OF THE M.BLUE HAD A PRESSURE OF 28,96 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 33 CMH2O ± 8 CMH2O. THE TEST, PERFORMED IN THE HORIZONTAL POSITION OF THE PROGAV 2.0 AT A REFERENCE FLOW OF 20 ML/H, HAS SHOWN THAT THE VALVE WITH A RESULT OF 7,39 CMH2O IS OPERATING WITHIN THE SPECIFIED TOLERANCE (8 CMH2O ± 3 CMH2O). ADJUSTABILITY TEST: THE M.BLUE AND THE PROGAV 2.0 WERE FOUND TO BE ADJUSTABLE TO ALL PRESSURE SETTINGS. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE OF THE GRAVITATIONAL UNIT OF BOTH VALVES WERE WITHIN THE SPECIFIED TOLERANCE AND THE BRAKE FUNCTION OPERATED AS EXPECTED. INTERNAL INSPECTION OF PRODUCT: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CANNOT CONFIRM THE COMPLAINT REASON OF SELF-ADJUSTMENT. WE CAN ONLY DETERMINE DEPOSITS. HOWEVER, THE DEPOSITS HAD NO EFFECT TO THE TECHNICAL PROPERTIES AT THE TIME OF THE INVESTIGATION. THE CAUSE OF THE AFOREMENTIONED FUNCTIONAL IMPAIRMENT IS NOT KNOWN TO US AT THE TIME OF THE EXAMINATION. 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 SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG. FROM OUR POINT OF VIEW, NO FURTHER REGULATORY ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A M.BLUE PLUS (#FX804T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE VALVES WERE BELIEVED TO BE ADJUSTING THEMSELVES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 18 YEARS. HEIGHT: 186 CENTIMETERS (CM). WEIGHT: 53 KILOGRAMS (KG). GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265830 M.BLUE PLUS VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX804T 20060234 04041906504793

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention