BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI APS DIALYZERS

    MDR report key: 2992221 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00140
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    June 21, 2007
    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 SERIES MARKETED IN US. FROM THE ANALYSIS RESULT, IT IS DIFFICULT TO CONCLUDE THERE WERE ANY ABNORMALITIES ON PERFORMANCE OF THE DIALYZER AND THE DIALYZER ITSELF. WE ALSO REVIEWED MANUFACTURING RECORDS, QUALITY RECORDS OF LOT #07ZW13. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. THE 10,785 UNITS OF THIS LOT #07ZW13 WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR EVENT USING THIS LOT #07ZW13 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. IMMEDIATELY BLOOD PRESSURE DECREASED (SYSTOLIC BLOOD PRESSURE: 115=>54MMHG), VOMITING, TACHYCARDIA, RASH AND DYSPNEA OCCURRED. AFTER THE ONSET OF THESE ADVERSE EVENTS, OXYGEN 10L, PHYSIOLOGICAL SALINE 400ML, DEXAMETHASONE SODIUM PHOSPHATE, DEXTRAN 40/LACTATE RINGER SOLUTION 500ML AND DOPAMINE HYDROCHLORIDE WERE ADMINISTERED. THEN BLOOD PRESSURE RECOVERED AND OTHER SYMPTOMS DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88779 ASAHI APS DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. APS-15SA 07ZW13

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening FUTHAN (NAFAMSTAT MESYLATE)