BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASAHI REXEED SERIES DIALYZERS

    MDR report key: 1960219 · Received November 17, 2010

    Report

    Report Number
    8010002-2010-00001
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ASAHI KASEI KURARAY MEDICAL CO., LTD.
    Product Code
    MSF
    PMA / PMN Number
    K051187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE QUALITY RECORDS INCLUDING THE MATERIAL INCOMING INSPECTIONS, IN-PROCESS TESTS AND THE PRODUCT RELEASE INSPECTION. HOWEVER, NO ABNORMALITY WAS FOUND. THE LEAKAGE TEST WAS PERFORMED ON EACH PRODUCT DURING THE MANUFACTURING PROCESS. AND NON-CONFORMING PRODUCTS ARE NOT RELEASED FROM THE PLANT. SO THE BROKEN HOLLOW FIBER THAT MAY CAUSE THE BLOOD LEAKAGE COULD BE CAUSE BY INADEQUATE CONDITION OF TRANSPORTATION, STORAGE, AND/OR HANDLING OF PRODUCTS.

    Description of Event or Problem · 1

    THE PT WAS TREATED ON HEMODIALYSIS USING THE REXEED-21R DIALYZER ON (B)(6) 2010. THE DIALYSIS EQUIPMENT ALARMED THE BLOOD LEAKAGE TWO OR THREE MINUTES AFTER STARTING THE EXTRACORPOREAL CIRCULATION. THE BLOOD CIRCULATION WAS STOPPED IMMEDIATELY. THE DIALYZER (THE PRODUCT FROM THE SAME BOX) AND THE BLOOD TUBE SET WERE REPLACED AND THE DIALYSIS TREATMENT WAS STARTED AGAIN. BUT THE EQUIPMENT WARNED THE BLOOD LEAKAGE AGAIN IN THE SAME TIMING AS THE FIRST TIME. THE DIALYZER (THE PRODUCT FROM THE SAME BOX) AND THE TUBE SET WERE CHANGED TO NEW ONES, AND THE TREATMENT WAS TRIED AGAIN. BUT THE EQUIPMENT DETECTED THE BLOOD LEAKAGE AGAIN. IN THE FOURTH TIME, THE NEW DIALYZER PICKED UP FROM THE DIFFERENT BOX. BUT THE BLOOD LEAK WAS DETECTED JUST AFTER RESTARTING THE BLOOD CIRCULATION. THE PT LOST ABOUT THE 1000ML OF BLOOD BECAUSE THE 250ML OF BLOOD REMAINED IN THE DIALYZER AND BLOOD TUBING SET WAS DISCARDED EACH TIME. THE BLOOD TRANSFUSION WAS NEEDED FOR THE PT IN THE ADDITIONAL HOSPITAL DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI REXEED SERIES DIALYZERS HEMODIALYZER, RE-USE, HIGH FLUX; MSF MSF ASAHI KASEI KURARAY MEDICAL CO., LTD. REXEED-21R M88N8U

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BLOOD TRANSFUSION