BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992272 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00200
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    May 20, 2010
    Report Date
    February 25, 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 #301X1A. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. THE 11,568 UNITS OF THIS LOT # WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT # WAS REPORTED GLOBALLY. 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) 2010: THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS (HD). AT 15 MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 140=>60MMHG) AND COMPLAINED DYSPNEA. AFTER TACHYCARDIA OCCURRED, DIALYSIS STOPPED TEMPORARILY. AFTER THE ONSET OF THESE ADVERSE EVENTS (AES), PHYSIOLOGICAL SALINE 200ML AND SOLU-CORTEF WERE ADMINISTERED, THEN BLOOD PRESSURE RECOVERED TO 130MMHG. THE DIALYZER WAS CHANGED TO ANOTHER TYPE, THEN HD WAS CONDUCTED WITHOUT PROBLEM. ON (B)(6) 2010: THE DIALYZER (APS-15SA) WAS USED FOR HD. BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: =>60MMHG) AND PT COMPLAINED CHEST PAIN AND OBSERVED YAWNING EXCESSIVE. AFTER THE ONSET OF THESE AES, PHYSIOLOGICAL SALINE 450ML WAS ADMINISTERED, THEN HD WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89467 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 301X1A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Life Threatening