BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI REXEED-LX SERIES DIALYZER

    MDR report key: 2568549 · Received May 4, 2012

    Report

    Report Number
    3007340888-2012-00120
    Event Type
    Injury
    Date Received
    May 4, 2012
    Date of Event
    February 8, 2012
    Report Date
    May 4, 2012
    Manufacturer
    ASAHI KASEI MEDICAL CO., LTD.
    Product Code
    KDI
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REXEED-15LX IS SIMILAR DEVICE MARKETED IN US, ASAHI REXEED-SX/LX DIALYZER (K082515). THE USED DEVICE COULD NOT BE ANALYZED BECAUSE IT WAS DISCARDED BY THE USER. NO ABNORMALITY WAS FOUND IN THE LOT QUALITY RECORDS OF THE USED PRODUCT. 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 UNK CAUSE. (B)(4).

    Description of Event or Problem · 1

    THE PT WAS TREATED ON THE HEMODIALYSIS WITH THE REXEED-18LX ON (B)(6) 2012. THE ANAPHYLACTIC REACTION OCCURRED 15 MINS AFTER ONSET OF THE TREATMENT. THE PT HAD BREATHLESSNESS AND THE DISSEMINATION OF WATER BLISTERS WAS OBSERVED. THE OXYGEN INHALATION WAS DONE. THE PT ADMINISTERED 8 MG OF DEXAMETHASONE AND 1 ML TAVEGYL, AND RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI REXEED-LX SERIES DIALYZER KDI ASAHI KASEI MEDICAL CO., LTD. REXEED-18LX 711U26

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention