BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992197 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00050
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    August 27, 2005
    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-21SA IS IDENTICAL MODEL TO REXEED-21S 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# W55F5L. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. (B)(4). THE SYMPTOMS OBSERVED IN THE EVENTS ARE CONSIDERED TO BE A DIALYZER REACTION. NOTE: THE DIALYZER REACTION IS A BROAD GROUP OF EVENTS THAT INCLUDE BOTH ANAPHYLACTIC AND LESS WELL-DEFINED ADVERSE REACTIONS OF UNKNOWN CAUSE. "HANDBOOK OF DIALYSIS 4TH ED." JOHN T DAUGIRDAS ET. AL., LIPPINCOTT, WILLIAMS & WILKINS, 2006.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE DIALYZER (APS-21SA) WAS USED FOR HEMODIALYSIS (HD). TEN TO FIFTEEN MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 180 = 75 MMHG), SWEATY AND DYSPNEA OCCURRED. AFTER THE ONSET OF THESE ADVERSE EVENTS (AES), PHYSIOLOGICAL SALINE (100-600 ML) AND EFFORTIL WERE ADMINISTERED, THEN THESE AES RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88742 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-21SA W55F5L

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention CIDEFERRON (FE)