BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE PLUS SYS W/CONTROL RESERVOIR

    MDR report key: 17051436 · Received June 2, 2023

    Report

    Report Number
    3004721439-2023-00155
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    May 1, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE INVESTIGATION, SCRATCHES ON THE OUTER HOUSING OF THE M.BLUE AND BLOODY RESIDUES AND DISCOLORATION ON THE CATHETER WERE DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE PROGAV 2.0 IS OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE HORIZONTAL POSITION. THE M.BLUE IS OPERATING NOT WITHIN THE SPECIFIED TOLERANCES IN BOTH POSITIONS. AN SLOWER OUTFLOW OF M.BLUE COULD BE DETERMINED. ADJUSTMENT TEST: THE M.BLUE AND PROGAV 2.0 WAS TESTED AND ARE 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 VALVES, DEPOSITS WERE FOUND 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 VALVE. BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE A SLOWER OUTFLOW IN THE M.BLUE VALVES AT THE TIME OF THE INVESTIGATION. 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 IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE. 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: 31 YEARS. HEIGHT: 160 CENTIMETERS (CM). WEIGHT: 50 KILOGRAMS (KG). GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948735 M.BLUE PLUS SYS W/CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX824T 20059572 04041906504830

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention