BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIFLUX

    MDR report key: 6048227 · Received October 20, 2016

    Report

    Report Number
    MW5065544
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 20, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY 5 MINUTES INTO DIALYSIS, PT HAD A CARDIAC ARREST. PHYSICIAN BELIEVES IT WAS AN ALLERGY TO HEMODIALYSIS DIALYZER. ACCORDING TO PT'S FAMILY, PT HAD A REACTION TO THIS DIALYZER BRAND AT HIS PREVIOUS DIALYSIS FACILITY WHICH WAS NOT REPORTED TO THE CURRENT FACILITY PRIOR TO INITIATING TREATMENT. PT HAS ESRD ON HEMODIALYSIS FOR 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696896 OPTIFLUX OPTIFLUX KDI FRESENIUS MEDICAL CARE F180NR 16CU03016

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death