BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992200 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00110
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    September 1, 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
    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# 065K5M. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. TEN THOUSAND TWO HUNDRED AND TWENTY FOUR UNITS OF THIS LOT# 065K5M WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT# 065K5M 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) 2006, THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS. AFTER TREATMENT START, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 200 = 61 MMHG). ADDITIONALLY VOMITING WAS OCCURRED. AFTER THESE ADVERSE EVENTS (AES) BY PHYSIOLOGICAL SALINE 350 ML, OXYGEN 5 L, SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) AND INOVAN (DOPAMINE HYDROCHLORIDE) WERE ADMINISTERED. THEN, BLOOD PRESSURE AND OTHER ADVERSE EVENTS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88759 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 065K5M

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening CARDENALIN (DOXAZOSIN MESILATE) 4 MG| ZYLORIC (ALLOPURINOL) 100 MG| ROCALTROL (CALCITRIOL) 0.25 UL| LASIX (FUROSEMIDE) 40 MG X 2| NU-LOTAN (LOSARTAN POTASSIUM) 50 MG| ATELEC (CILNIDIPINE) 10 MG| FLUITRAN (TRICHLORMETHIAZIDE) 2 MG| RENIVACE (ENALAPRIL MALEATE) 5 MG X 3| LIPOVAS (SIMVASTATIN) 5 MG| MUCOSTA (REBAMIPIDE) 100 MG X 3