BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992219 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00100
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    July 14, 2006
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(6) AND IS REPORTED TO FDA ACCORDING TO THE REQUIREMENT. APS-21UA IS IDENTICAL MODEL TO REXEED-21U 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# R63R3W. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. (B)(4) OF THIS LOT# R63R3W WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT# R63R3W 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 AND WILKINS, 2006.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE DIALYZER ((B)(4)) WAS USED FOR HEMODIALYSIS (HD). FIVE TO TEN MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 160 = 72 MMHG). ADDITIONALLY VOMITING AND PREDICTIVE SYMPTOMS OF SLIGHT CONVULSION OCCURRED. AFTER THE ONSET OF BLOOD PRESSURE DECREASED, PHYSIOLOGICAL SALINE 500 ML WAS ADMINISTERED. THEN BLOOD PRESSURE STARTED TO RECOVER GRADUALLY. WITH ADDITIONAL 300 ML OF PHYSIOLOGICAL SALINE, BLOOD PRESSURE BECAME NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89292 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-21UA R63R3W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening