BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992199 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00080
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    April 4, 2007
    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-13SA 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# N6ZYZF. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. (B)(4). AT THESE REACTIONS OCCURRED 3 HOUR AFTER START OF TREATMENT, THESE ARE LIKELY MORE RELATED TO EXCESS ULTRA FILTRATION AND LACK OF NORMAL COMPENSATORY RESPONSE OF PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE DIALYZER (APS-13SA) WAS USED FOR HEMODIALYSIS (HD). THREE HOUR AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 136 = 78 MMHG). ADDITIONALLY ABDOMINAL PAIN AND VOMITING OCCURRED. AFTER THE ONSET OF THESE SYMPTOMS, PHYSIOLOGICAL SALINE 200 ML AND OXYGEN 2 L WAS ADMINISTERED. THE PATIENT RECOVERED AND WENT BACK TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89264 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-13SA N6ZYZF

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention