BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO CELLENTIA-H DIALYZER

    MDR report key: 25151282 · Received May 12, 2026

    Report

    Report Number
    9610987-2026-00035
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 12, 2026
    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

    APPROXIMATELY 15 MINUTES AFTER INITIATING DIALYSIS TREATMENT, PATIENT DEVELOPED DYSPNEA, PROFUSE SWEATING, CONJUCTIVAL EDEMA, FACIAL FLUSHING AND HYPOTENSION. THE DOCTOR IMMEDIATLY TERMINATED THE DIALYSIS TREATMENT. FOLLOWING THE ONSET OF SUMPTOMS, 5MG OF DECAMETHASONE WAS ADMINISTERED INTRAVENOUSLY AND OXYGEN THERAPY WAS INITIATED PROMPTLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526520 NIPRO CELLENTIA-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) FB-17U 25I29E

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| O