BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI REXEED-S DIALYZERS

    MDR report key: 2992196 · Received March 1, 2013

    Report

    Report Number
    8010002-2013-00030
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    December 31, 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
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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# M74147. AS A RESULT, NO ABNORMALITY WAS FOUND IN RECORDS. TWELVE THOUSAND THREE HUNDRED AND THIRTY EIGHT UNITS OF THIS LOT# M741477 WERE DISTRIBUTED TO THE MEDICAL FACILITIES AND NO SIMILAR SAE USING THIS LOT# M74147 WAS REPORTED GLOBALLY. THIS EVENT IS CONSIDER AS POSSIBLE ACUTE HEMOLYSIS ALTHOUGH RELATIONSHIP TO DIALYZER MEMBRANE CANNOT BE DENIED COMPLETELY.

    Description of Event or Problem · 1

    NAUSEA AND BLOOD PRESSURE DECREASED ONE HOUR AFTER INITIATION OF THE TREATMENT ON (B)(6) 2007. BLOOD APPEARED TO CHANGE COLOR TO BROWN. THE TREATMENT WAS DISCONTINUED AND THE DIALYZER WAS REPLACED WITH THE SAME LOT PRODUCT. WITH THE SECOND SYSTEM, SEVERE NAUSEA AND BLOOD PRESSURE DECREASED AGAIN IMMEDIATELY AFTER INITIATION OF THE TREATMENT. BLOOD OXYGEN SATURATION LEVEL WENT DOWN TO 60%. THE TREATMENT WAS DISCONTINUED. AFTER THE PROCEDURE IN ANOTHER FACILITY, THE SYMPTOM WAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89263 ASAHI REXEED-S DIALYZERS KDI ASAHI KASEI MEDICAL CO., LTD. REXEED-21S M74147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening