BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE PLUS SYS W.CONTROL RESERVOIR

    MDR report key: 17051419 · Received June 2, 2023

    Report

    Report Number
    3004721439-2023-00156
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    April 30, 2023
    Report Date
    June 2, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906504830
    PMA / PMN Number
    K192266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE INVESTIGATION, DEPOSITS ON THE DEVICE BUT NO DAMAGES WAS DETERMINED. THE CONTROL RESERVOIR WAS DISCONNECTING AND AN ADDITIONAL CATHETER WAS CONNECTED ON THE INLET OF THE PROGAV 2.0. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. DURING THE PERMEABILITY TEST SOME PARTICLES WERE FLUSHED OUT. 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE PROGAV/PROGAV 2.0 IS OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE HORIZONTAL POSITION. THE M.BLUE IS OPERATING NOT WITHIN THE SPECIFIED TOLERANCES IN THE VERTICAL POSITION. AN SLOWER OUTFLOW OF M.BLUE COULD BE DETERMINED. ADJUSTMENT TEST: BOTH VALVES WERE TESTED AND ARE ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTIONS ARE FULLY OPERATIONAL AND THE BRAKING FORCES ARE WITHIN THE GIVEN TOLERANCES. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND AFTER THE COLORING IN BOTH VALVES. RESULTS : IN ADVANCE, WE WOULD LIKE TO POINT OUT THAT THE PRODUCT SENT IN WAS NOT SUBMERGED IN LIQUID AT THE TIME OF DELIVERY. THE TESTING OF DRY VALVES IS ONLY OF LIMITED VALUE. THE PRODUCT PROPERTIES CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD. DESPITE THIS, WE HAVE EXAMINED THE VALVES. BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A SLOWER OUTFLOW IN THE SHUNT SYSTEM. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE SLOWER 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 SHUNT SYSTEM 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 PLUS (#FX824T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6), 2023. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 37 YEARS. HEIGHT: 150 CENTIMETERS (CM). WEIGHT: 80 KILOGRAMS (KG). GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947906 M.BLUE PLUS SYS W.CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX824T 20063454 04041906504830

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention