BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992217 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00090
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    July 6, 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-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# 26393Y. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. EIGHT THOUSAND TWO HUNDRED AND NINETY TWO UNITS OF THIS LOT# 26393Y WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT# 26393Y 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 (HD). IMMEDIATELY BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 160 = 60 MMHG). ADDITIONALLY DYSPNEA, CHEST PAIN, ITCHING, RASH, NUMBNESS OF LIPS AND LIP SWELLING OCCURRED. AFTER THE ONSET OF BLOOD PRESSURE DECREASED, HEMODIALYSIS STOPPED AND PHYSIOLOGICAL SALINE ADMINISTERED 400 ML, BUT BLOOD PRESSURE DID NOT RECOVER AND THE PATIENT VOMITED. THEN ALBUMIN PREPARATION 50 ML WAS ADDED AFTER THAT METHYLPREDNISOLONE SODIUM SUCCINATE 250 MG WAS INTRAVENOUSLY INJECTED FOR ONE HOUR. AFTER THESE TREATMENT BLOOD PRESSURE RECOVERED AND BECAME STABLE THEN PATIENT WAS TREATED BY DIFFERENT TYPE OF DIALYZER WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89276 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 26393Y

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening PHOSBLOCK (SEVELAMER HYDROCHLORIDE)| BAYASPIRIN (ASPIRIN)| METHYCOBAL (MECOBALAMIN)| CINAL (ASCORBIC ACID/CALCIUM PANTOTHENATE)| JUVELA N (TOCOPHEROL NICOTINATE)