BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO CELLENTIA-H DIALYZER

    MDR report key: 23885922 · Received December 23, 2025

    Report

    Report Number
    9610987-2025-00028
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 23, 2025
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K160444
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING HEMODIAFILTRATION, THE PATIENT EXPERIENCED PROFUSE SWEATING AND DYSPNEA 10 MINUTES INTO THE TREATMENT. SUBSTITUTION WAS IMMEDIATELY STOPPED. THE PATIENT WAS ADMINISTERED LOW-FLOW OXYGEN AND INTRAVENOUS DEXAMETHASONE SODIUM PHOSPHATE INJECTION 10MG, TO RELIEVE DYSPNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829455 NIPRO CELLENTIA-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) FB-17U (CELLENTIA-H) 25E29E

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Other