BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 14380312 · Received May 12, 2022

    Report

    Report Number
    9610987-2022-00002
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 2, 2022
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K140191
    Product Problem
    Yes
    Report Source
    Manufacturer 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.

    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
    415556 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) DD+ELISIO-25H 21I27E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other