BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 23653287 · Received November 25, 2025

    Report

    Report Number
    9610987-2025-00027
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 25, 2025
    Report Date
    December 9, 2025
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    Product Problem
    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 TREATMENT, THE BLOOD LEAK ALARM ACTIVATED, AND THE PROCEDURE WAS STOPPED. BLOOD WAS NOT RETURNED; BLOOD FROM THE EXTRACOPOREAL SYSTEM WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED 11/26/2025: PATIENT DID NOT ENCOUNTER ANY SYMPTOMS, BLOODLINE WAS DISCARDED, MACHINE WAS SHUT DOWN, STAFF REPLACED FULL SET OF CONSUMABLES, AND TREATMENT WAS CONTINUED.

    Description of Event or Problem · 0

    DURING TREATMENT, THE BLOOD LEAK ALARM ACTIVATED, AND THE PROCEDURE WAS STOPPED. BLOOD WAS NOT RETURNED; BLOOD FROM THE EXTRACORPOREAL SYSTEM WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538155 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-17H 25D24C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other