BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE PLUS SYS W/CONTROL RESERVOIR

    MDR report key: 18312219 · Received December 12, 2023

    Report

    Report Number
    3004721439-2023-00362
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 12, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    00401906504830
    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

    INVESTIGATION: VISUAL INSPECTION DURING THE INVESTIGATION, SCRATCHES ON THE OUTER HOUSING OF THE VALVE, BUT NO SIGNIFICANT DEFORMATIONS OR DAMAGE WAS DETERMINED. PERMEABILITY TEST A PERMEABILITY TEST HAS INDICATED THAT THE M.BLUE VALVE IS PERMEABLE. COMPUTER CONTROLLED TEST TO INVESTIGATE THE CLAIM OF UNDER-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 IS OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE HORIZONTAL POSITION, BUT NOT WITHIN THE SPECIFIED TOLERANCES IN THE VERTICAL POSITION. AN ACCELERATED OUTFLOW OF M.BLUE COULD BE DETERMINED. ADJUSTMENT TEST THE M. BLUE VALVE WAS TESTED AND IS PARTIALLY ADJUSTABLE (FROM 22 TO 24 CMH2O). BRAKING FORCE AND BRAKE FUNCTION TEST THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS OPERATIONAL, HOWEVER THE BRAKING FORCE CANNOT BE MEASURED DUE TO THE LIMITED ADJUSTABILITY OF THE VALVE. 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 ACCELERATED OUTFLOW. 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

    IT WAS REPORTED THAT A M.BLUE (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 12 YEARS HEIGHT: 135 CM WEIGHT: 35 KG GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289324 M.BLUE PLUS SYS W/CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX824T 20052916 00401906504830

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention