BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992220 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00120
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 27, 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
    BIOMEDICAL ENGINEER

    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# 068G8J. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. TEN THOUSAND EIGHT HUNDRED AND FORTY TWO UNITS OF THIS LOT# 068G8J WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT# 068G8J 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) 2007, THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS. THIRTY MINUTE AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 142 = 70 MMHG), NAUSEA, VOMITING, AND CHEST PAIN OCCURRED. AFTER THE ONSET OF THESE ADVERSE EVENTS , ETILEFRINE HYDROCHLORIDE, METOCLOPRAMIDE, PHYSIOLOGICAL SALINE 100 ML AND GLYCERINE WERE ADMINISTERED, BLOOD PRESSURE RECOVERED TO 138 MMHG AND OTHER ADVERSE EVENTS ALSO RECOVERED. ON (B)(6) 2007, THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS. TWENTY MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 148 = 75 MMHG), NAUSEA AND COMPLEXION ILL OCCURRED. AFTER THE ONSET OF THESE ADVERSE EFFECTS, ETILEFRINE HYDROCHLORIDE, GLYCERINE AND PHYSIOLOGICAL SALINE 100 ML WERE ADMINISTERED. THEN BLOOD PRESSURE RECOVERED TO 128 MMHG AND OTHER ADVERSE EFFECTS RECOVERED. ON (B)(6) 2007, BEFORE DIALYSIS START AMEZINIUM METILSULFATE WAS ADMINISTERED. THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS. THIRTY MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 185 = 112 MMHG), NAUSEA AND COMPLEXION ILL OCCURRED. AFTER THESE ADVERSE EVENTS, ETILEFRINE HYDROCHLORIDE AND EPHEDRINE HYDROCHLORIDE WERE ADMINISTERED. THEN BLOOD PRESSURE RECOVERED TO 150 MMHG AND OTHER ADVERSE EVENTS RECOVERED. ON (B)(6) 2007, THE DIALYZER (APS-15SA) WAS USED FOR HEMODIALYSIS. TWENTY MINUTES AFTER START OF TREATMENT, BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 162 = 75 MMHG) AND VOMITING OCCURRED. AFTER THESE ADVERSE EVENTS, HYDROCHLORIDE AND EPHEDRINE HYDROCHLORIDE WERE ADMINISTERED. THEN THESE ADVERSE EVENTS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89277 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 068G8J

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention