BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992198 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00060
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 23, 2006
    Report Date
    March 1, 2013
    Manufacturer
    ASAHI KASEI MEDICAL CO., LTD.
    Product Code
    KDI
    PMA / PMN Number
    K051187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(6) AND IS REPORTED TO FDA ACCORDING TO THE REQUIREMENT. APS-21SA IS IDENTICAL MODEL TO REXEED-21S MARKETED IN US. THE USED DEVICE LOT # WAS NOT AVAILABLE BECAUSE THE PRODUCT WAS DISCARDED BY THE HEALTHCARE FACILITY. THIS PATIENT WAS DIALYZED ON LARGE SURFACE AREA DIALYZER WITH HIGHER BLOOD FLOW RATE THAN NORMAL USE, WHICH RESULTED IN SHOCK.

    Description of Event or Problem · 1

    THE DIALYZER WAS USED FOR ELDERLY PATIENT. THE BLOOD FLOW RATE WAS TOO FAST FOR PATIENT. SO, THE PATIENT WENT INTO SHOCK AND HOSPITALIZED ONE DAY. AFTER THIS ADVERSE EVENT, DIALYZER WAS CHANGED TO 21SA AND THE PATIENT BECAME WELL WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89283 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-25SA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening