BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.BLUE 0 VALVE

    MDR report key: 12537630 · Received September 27, 2021

    Report

    Report Number
    3004721439-2021-00276
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    July 1, 2021
    Report Date
    October 13, 2021
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXH
    UDI-DI
    04041906504397
    PMA / PMN Number
    K192266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND QUALITY CONTROL DATA THE M.BLUE® WAS MANUFACTURED BY A QUALIFIED EMPLOYEE ON (B)(6) 2021. DEVIATIONS DURING ASSEMBLY DID NOT OCCUR. THE PRODUCT WAS FINALLY TESTED AS ARTICLE FX800T AND RELEASED FOR PACKAGING AND STERILIZATION AND WAS STERILIZED BY MIETHKE. THE M.BLUE® HAS A NORMAL PRESSURE RANGE OF 0 TO 40 CMH2O. A FIXED OPENING PRESSURE OF 0 CMH2O IN THE HORIZONTAL POSITION (DIFFERENTIAL PRESSURE UNIT) AND AN ADDITIONAL ADJUSTABLE GRAVITATIONAL UNIT OF 0 TO 40 CMH2O IN THE VERTICAL POSITION. BOTH REALIZED IN ONE VALVE. THE PARAMETERS AFTER COMPLETION OF THE VALVE ASSEMBLY WERE TESTED AT A FLOW RATE OF 5 ML/H OR 50 ML/H AT THE GRAVITATIONAL UNIT SET PRESSURES AND 0, 10, 20, 30 AND 40 CMH2O AT THE DIFFERENTIAL PRESSURE UNIT OF 0 CMH2O, AND WERE FOUND TO MEET SPECIFICATIONS. ALL TESTED PARAMETERS WERE ASSESSED ACCORDING TO SPECIFICATIONS. VISUAL INSPECTION THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: - NO VISIBLE DEFECTS DETECTED. PERMEABILITY TEST THE TEST SHOWED THAT THE M.BLUE® IS PERMEABLE. COMPUTER CONTROL TEST THIS VALVE OPERATED IN THE VERTICAL POSITION NOT WITHIN THE SPECIFIED TOLERANCE (UNDER-DRAINAGE). ADJUSTABILITY TEST THE M.BLUE® WAS FOUND TO BE ADJUSTABLE TO ALL PRESSURE SETTINGS. BRAKING FORCE AND BRAKE FUNCTION TEST THE BRAKING FORCE OF THE GRAVITATIONAL UNIT OF THE M.BLUE® WAS WITHIN THE SPECIFIED TOLERANCE AND THE BRAKE FUNCTION OPERATED AS EXPECTED. INTERNAL INSPECTION OF PRODUCT AFTER DISMANTLING OF THE VALVE, NO VISIBLE DEPOSITS WERE FOUND IN M.BLUE®. RESULTS BASED ON OUR INVESTIGATION RESULTS, WE CAN IDENTIFY AN "ACCELERATED OUTFLOW" ON THE VALVE. IT IS POSSIBLE THAT DEPOSITS WERE REMOVED BY OUR TESTS WITH LIQUID. EVEN NON-VISIBLE DEPOSITS INSIDE THE VALVE CAN AFFECT THE FUNCTION OF THE VALVE. DEPOSITS CAUSED BY NATURAL SUBSTANCES IN THE CEREBROSPINAL FLUID, SUCH AS PROTEIN, BLOOD OR TISSUE PARTICLES, ARE AMONG THE KNOWN AND UNAVOIDABLE RISKS AND SIDE EFFECTS OF HYDROCEPHALUS THERAPY. SMALL AMOUNTS OF NON-VISIBLE DEPOSITS/PROTEINS MIGHT BE COMPROMISE THE INTEGRITY OF THE VALVE. 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.

    Description of Event or Problem · 0

    INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A M.BLUE (PART # FX800T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATING IN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: (B)(6). HEIGHT: 164 CENTIMETERS (CM). WEIGHT: (B)(6). GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430515 M.BLUE 0 VALVE HYDROCEPHALUS MANAGEMENT JXH CHRISTOPH MIETHKE GMBH & CO KG FX800T 20052719 04041906504397

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention