BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992256 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00210
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    August 2, 2010
    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

    ADDITIONAL INFORMATION FOR LOT # 30373B. 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 U.S. THE USED DEVICE COULD NOT BE ANALYZED BECAUSE IT WAS DISCARDED BY THE USER FACILITY. SO WE REVIEWED MANUFACTURING RECORDS, QUALITY RECORDS OF LOT #30373X, AND 303Y3B. AS A RESULT, NO ABNORMALITY WERE FOUND IN RECORDS. THE 7,968 UNITS OF THIS LOT #30373X AND 8,616 UNITS OF THIS LOT #303Y3B WERE DISTRIBUTED TO THE MEDICAL FACILITIES RESPECTIVELY, AND NO SIMILAR EVENT USING THESE LOT #30373X AND 303Y3B WERE 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: LOT#30373X) WAS USED FOR HEMODIALYSIS (HD). AT 20 MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE (BP) DECREASED (SYSTOLIC BP: 192=>66MMHG). AFTER THE ONSET OF THESE ADVERSE EVENTS, PHYSIOLOGICAL SALINE 500ML AND 10% NAC1 FOR INJECTION 20ML WERE ADMINISTERED, AND LEG ELEVATED, THEN BLOOD PRESSURE RECOVERED TO 160MMHG. ON (B)(6) 2010: THE DIALYZER (APS-15SA: LOT#303Y3B) WAS USED FOR HD. IMMEDIATELY, BLOOD PRESSURE DECREASED. AFTER 40 MINUTES PASSED BP RECOVERED GRADUALLY, SYSTOLIC BLOOD PRESSURE STABLED AT 140MMHG. THE DIALYZER WAS NOT CHANGED ANOTHER ONE, THEN HD WAS CONDUCTED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89479 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 30373X

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention