BEUDAMED
    FDA Adverse Event Death Summary report: N

    PAEDIGAV SYSTEM W/PRECHAMBER 9/24

    MDR report key: 7920721 · Received September 28, 2018

    Report

    Report Number
    3004721439-2018-00229
    Event Type
    Death
    Date Received
    September 28, 2018
    Date of Event
    July 28, 2018
    Report Date
    September 28, 2018
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K011030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: IMPLANTED 2017: DAY AND MONTH UNKNOWN AT THIS TIME. THE VALVE WAS FITTED ON (B)(4) 2015 BY A QUALIFIED EMPLOYEE MANUFACTURED. NO ABNORMALITIES DURING ASSEMBLY OCCURRED. THE VALVE WAS RELEASED FOR PACKAGING AND STERILIZATION BY THE COMPANY'S AUTOCLAVE. THE VALVE HAD THE NOMINAL PRESSURED LEVEL 9/24 CMWS AND WAS DESIGNATED AS ARTICLE FV286T TESTED AND RELEASED FOR SHIPPING. THE VALVE CHARACTERISTICS AFTER CLOSING THE VALVE WITHOUT HOSE AT 5 ML / H AND 50 ML / H FLOW WERE ALRIGHT. THE TIGHTNESS OF THE SYSTEM HAS BEEN TESTED AND PROVEN. ALL CONTROLLED CHARACTERISTIC VALUES WERE WITHIN THE REQUIRED SPECIFICATION. IN THE FIRST STEP OF THE INVESTIGATIONS, THERE WAS A VISUAL INSPECTION PERFORMED ON THE VALVE. THE OPTICAL INVESTIGATION HAS SHOWN THAT THE VALVE HAS NO DEFORMATIONS OR ABNORMALITIES. PENETRATION TEST: TO CHECK IF THE VALVE IS CLOGGED, A PERMEABILITY TEST WAS PERFORMED. THIS TEST IS AT A HYDROSTATIC PRESSURE DIFFERENCE OF APPROX. 24-35 CMH2O IN FLOW DIRECTION CARRIED OUT. THE TEST HAS SHOWN THAT THE VALVE IS PERMEABLE. TEST AT THE COMPUTER TEST BENCH: MIETHKE TESTED THE VALVE, THE STANDARD TEST FOR BOTH THE STANDING AND THE LYING POSITION RUN THROUGH. THE LIQOURFLOW OF 60 ML / H GRADUALLY TO 5 ML / H REDUCED AND INCREASED AGAIN TO 60 ML / H (BASED ON ISO 7197). OF THE RESULTING PRESSURE IS MEASURED. RESULT: THE PAEDIGAV AT THE TIME OF DELIVERY WAS NOT IN LIQUID FORM. THE TESTING DRY SENT VALVES IS ONLY LIMITED MEANINGFUL. THE PRODUCT PROPERTIES ARE DUE TO DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD TO BE INFLUENCED. NEVERTHELESS, WE EXAMINED THE VALVE. IN THE FIRST STEP OF THE INVESTIGATIONS, THERE WAS A VISUAL INSPECTION PERFORMED ON THE VALVE. DEFORMATIONS OR OTHER ABNORMALITIES COULD NOT BE DETERMINED. INVESTIGATION THE SUSPICION OF CONSTIPATION, ONE WAS FOUND. PERMEABILITY TEST PERFORMED ON THE VALVE. THE PADIGAV WAS POSITIVELY TESTED FOR PERMEABILITY. IT COULD ALSO BE THAT THE FIRST FUNCTIONAL CHECK OF THE OPENING PRESSURES WAS SUCCESSFULLY DEMONSTRATED. TO GET THE DETAILED INFORMATION ABOUT THE FUNCTIONALITY OF THE PAEDIGAV WAS OBTAINED. THE VALVE WAS TESTED BENCH MEASUREMENT IN THE HORIZONTAL AS WELL AS IN VERTICAL POSITION. TEST BENCH MEASUREMENT - HORIZONTAL POSITION WAS SET OPENING PRESSURE OF 9/24 CMH2O RESULTING PRESSURE IN LYING BODY POSITION OF 9 CMH2O TO BE EXPECTED. THE MEASUREMENT HAS SHOWN THAT THE VALVE IS IN THE REFERENCE FLOW RANGE OF 5 ML / H IN HORIZONTAL BODY POSITION OUT OF TOLERANCE (9 CMH2O ± 2 CMH2O). THE VALVE TENDS TO BE OVER DRAINED. TEST BENCH MEASUREMENT - STANDING POSITION: STARTING FROM A PRESSURE LEVEL OF 9/24 CMH2O WAS ACCORDING TO HYDROSTATIC PRESSURE OF 24 CMH2O SET. AT A VALVE OPENING PRESSURE OF 24 CMH2O IS A RESULT PRESSURE TO BE EXPECTED IN AN UPRIGHT POSITION OF 0 CMH2O (PHYD - PÖFF = 0); I.E. THE RESULT FROM THE HEIGHT DIFFERENCE PRESSURE IS COMPENSATED. TEST IN THE VERTICAL POSITION HAS SHOWN THAT THE VALVE IN REFERENCE FLOW RANGE OF 5 ML / H IN THE VERTICAL POSITION AS WELL AS OUTSIDE TOLERANCE WORKS (0 CMH2O ± 4 CMH2O), ALSO IN THE VERTICAL POSITION THERE IS A TENDENCY TO OVER DRAINED. IN ORDER TO VERIFY THAT THE VALVE TESTED HERE WAS REPLACED BY THE KNOWN RISKS OF HYDROCEPHALUS THERAPY. EXAMPLE OF NATURAL CEREBROSPINAL SUBSTANCES IS (PROTEIN, BLOOD OR TISSUE PARTICLES). BLOCKAGE OF THE VALVE WAS NOT CONFIRMED. THE RESULTS FROM THE MEASUREMENT, TEND TO OVER DRAIN. THE VALVE WAS DELIVERED DRY, THE PAEDIGAV COULD NOT BE CONFIRMED IN THE CONDITION WAS FOUND. IT IS NOTICEABLE, THAT THE VALVE WAS CLEARLY NOT BLOCKED. THROUGH THE FOUND DEPOSITS, WHICH ARE KNOWN AS "SIDE EFFECT" IN THE HYDROCEPHALUS TREATMENT THAT OCCURRED, IN WHICH THE FUNCTION WAS RESTRICTED (TENDENCY TO OVER DRAINAGE). AT THE TIME OF DELIVERY THE DEFECT WAS EXCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE ""THE ABOVE MENTIONED PATIENT HAD A KNOWN OCCLUSIVE HYDROCEPHALUS TREATED WITH A VENTRICULOPERITONEAL SHUNT. THE ABOVE MENTIONED VALVE WAS IMPLANTED. ON THE DAY OF THE EVENT, THE PATIENT WAS ADMITTED TO OUR CLINIC IN A COMATOSE STATE AND AFTER A RESUSCITATION; ON CT A CLEAR HYDROCEPHALUS WAS SHOWN. IN A NOTOP, THE SHUNT SYSTEM WAS CHECKED AND A LOSS OF FUNCTION OF THE VALVE WAS DETECTED. THIS WAS THEN REPLACED BY AN IDENTICAL. UNFORTUNATELY, THE PATIENT UNFORTUNATELY DIED AS A RESULT OF A PROBABLY INITIAL OXYGEN DEFICIT. THE DESCRIBED DEFECT OF THE VALVE IS CERTAINLY PLAUSIBLE AS A CAUSE OF THE COMA WHICH HAS OCCURRED, IN PARTICULAR SINCE THE PATIENT PROBABLY ALREADY COMPLAINED OF HEADACHES IN THE DAYS BEFORE. THE WITHDRAWN VALVE WAS STORED IN OUR OR DEPARTMENT AND COULD BE RETRIEVED FOR FURTHER ANALYSIS IF NECESSARY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759540 PAEDIGAV SYSTEM W/PRECHAMBER 9/24 HYDROCEPHALUS VALVES JXG CHRISTOPH MIETHKE GMBH & CO. KG FV286T 20028330

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death