BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REXEED SERIES DIALYZERS

    MDR report key: 4223602 · Received October 30, 2014

    Report

    Report Number
    8010002-2014-00040
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    November 18, 2013
    Report Date
    October 1, 2014
    Manufacturer
    ASAHI KASEI MEDICAL CO., LTD.
    Product Code
    KDI
    PMA / PMN Number
    K051187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(4) AND IS REPORTED TO FDA ACCORDING TO THE REQUIREMENT. 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. "HANDBOOK OF DIALYSIS 4TH EDITION."

    Description of Event or Problem · 1

    ON (B)(6) 2013: 15-20MIN AFTER START OF TREATMENT, THE PT GOT FIDGET, SWEATING, HYPOXIA, NAUSEA, AND HYPOTENSION (140MMHG/90MMGH) THEN CALLED PHYSICIAN ADMINISTRATED 1 AMPLE OF CHLORPHENIRAMINE AND DEXAMETHASONE I.V., GAVE OXYGEN AND RETURNED BLOOD TO THE PT. OUTCOME OF PT: RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696622 REXEED SERIES DIALYZERS DIALYZER, HIGH PERMEABILITY KDI ASAHI KASEI MEDICAL CO., LTD. REXEED-21A QA858X

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention TUBING SET: BAIN| DIALYSIS MACHINE: FRESENIUS