BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 14380379 · Received May 12, 2022

    Report

    Report Number
    1056186-2022-00001
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 12, 2022
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    1 HOUR INTO DIALYSIS TREATMENT, MACHINE ALARMED FOR BLOOD IN THE DIALYSATE. STAFF WAS UNABLE TO CONFIRM BLOOD LEAK WITH A BLOOD LEAK STRIP. BFR OF 440ML/HR AND DFR OF 800ML/HR. TREATMENT WAS STOPPED, BLOOD WAS NOT RETURNED. NEW MACHINE SET UP WAS STARTED AND COMPLETED THE TREATMENT WITHOUT ISSUES. PATIENT'S HGB AT START OF THE MONTH WAS 10G/DL. LABS WILL BE DRAWN (B)(6) 2022 TO SEE HGB LEVELS. ON (B)(6) 2022: CLINIC CONFIRMED THAT THEY INCREASED ARANESP FROM 10MCG TO 25MCG WEEKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364680 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-25H 21I27E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other