BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 23176256 · Received September 29, 2025

    Report

    Report Number
    9610987-2025-00017
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    July 19, 2025
    Report Date
    September 25, 2025
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WITHIN ONE HOUR OF TREATMENT INITIATION, THE PATIENT COMPLAINED OF PALPITATIONS AND DYSPNEA. OXYGEN SATURATION DECREASED TO 69%, AND ELECTROCARDIOGRAPHY CONFIRMED ATRIAL FIBRILLATION, INDICATING ACUTE EXACERBATION OF CHRONIC HEART FAILURE. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469479 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-19H 25D03P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R