BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992273 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00240
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    April 27, 2011
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(6) AND IS REPORTED TO FDA ACCORDING TO THE REQUIREMENT. APS-15SA IS IDENTICAL MODEL TO REXEED-15S MARKETED IN US. THE USED DEVICE COULD NOT BE ANALYZED BECAUSE IT WAS DISCARDED BY THE USER FACILITY. SO WE REVIEWED MANUFACTURING RECORDS, QUALITY RECORDS OF LOT #10787Y AND OTHER 14 LOTS WHICH HAVE POSSIBILITY USED FOR TREATMENT. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. AS THIS REACTION OCCURRED 1 HOUR AFTER START OF TREATMENT, THIS IS LIKELY MORE RELATED TO EXCESS ULTRA FILTRATION AND LACK OF NORMAL COMPENSATORY RESPONSE OF PT.

    Description of Event or Problem · 1

    ON (B)(6) 2011: THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS (HD). A 60 MINUTES AFTER START OF TREATMENT, DYSPNEA WAS OCCURRED. AFTER THE ONSET OF THIS ADVERSE EVENT (AE), OXYGEN WAS ADMINISTERED. THE DIALYZER WAS CHANGED ANOTHER TYPE AT THE NEXT TIME, THEN HD WAS CONDUCTED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88863 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 10787Y ETC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention