BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI KASEI MEDICAL

    MDR report key: 1156007 · Received September 10, 2008

    Report

    Report Number
    MW5008257
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 3, 2008
    Manufacturer
    ASAHI KASEI MEDICAL AMERICA INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BLOOD LEAK ALARMS DURING THE HEMO DIALYSIS TREATMENT. NO PT ADVERSE REACTION NOTED. BLOOD LOSS 250-350 CCS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI KASEI MEDICAL SINGLE USE HEMODIALYZER (CLASS II) MEDICAL DEVICE KDI ASAHI KASEI MEDICAL AMERICA INC. REXEED 15S P7YG4L
    2 ASAHI KASEI MEDICAL SINGLE USE HEMODIALYZER (CLASS II) MEDICAL DEVICE KDI ASAHI KASEI MEDICAL AMERICA INC. REXEED 18S U8282A

    Patients

    Seq Age Sex Outcome Treatment
    1