BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI AM-BIO SERIES DIALYZERS

    MDR report key: 473229 · Received July 16, 2003

    Report

    Report Number
    8010002-2003-00039
    Event Type
    Malfunction
    Date Received
    July 16, 2003
    Report Date
    July 16, 2003
    Manufacturer
    ASAHI MEDICAL CO., LTD.
    Product Code
    MSE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAKS OCCURRED AFTER START OF HEMODIALYSIS TREATMENT. THE LEAK WAS OBSERVED WITH LEAK DETECTOR. THE BLOOD LOSS VOLUME WAS BETWEEN 100ML AND 200ML. THE DIALYZERS WERE AT THE 2ND -14TH REUSE. THE DIALYSIS CENTER REPORTED THAT 5 BLOOD LEAKS OCCURRED IN TWO DIFFERENT LOTS. HOWEVER, THE NUMBERS OF PTS OR, PRODUCTS NUMBER PER EACH LOT ARE UNK. PLEASE REFER TO 8010002-2003-38.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI AM-BIO SERIES DIALYZERS HEMODIALYZER MSE ASAHI MEDICAL CO., LTD. AM-BIO-100 731K1Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN