BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO ELISIO H DIALYZER

    MDR report key: 21976328 · Received May 7, 2025

    Report

    Report Number
    9610987-2025-00008
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 7, 2025
    Report Date
    June 4, 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

    BLOOD LEAK OCCURRED DURING HEMODIAFILTRATION (HDF) TREATMENT, DIALYZER IS USED FOR ONLINE HEMODIAFILTRATION (OL-HDF), PRIMING OF THE DIALYZER WAS NORMAL, AND BLOOD LEAK ALARM IS TRIGGERED AT ABOUT 15 MINS AFTER TREATMENT BEGAN, THE NURSE CHECKED THE DIALYZER, THERE WAS NO EXACT LEAKING SPOT BUT DIALYSATE TURNED RED. UNABLE TO RETURN THE PATIENT'S BLOOD, NURSE CHANGED TO A NEW DIALYZER. NO FURTHER ISSUES OCCURRED. QB 250 ML/MIN, QD 500 ML/MIN, TMP 0MMHG, CONVECTION TARGET - 30L.

    Description of Event or Problem · 0

    BLOOD LEAK OCCURRED DURING HEMODIAFILTRATION (HDF) TREATMENT, DIALYZER IS USED FOR ONLINE HEMODIAFILTRATION (OL-HDF), PRIMING OF THE DIALYZER WAS NORMAL, AND BLOOD LEAK ALARM IS TRIGGERED AT ABOUT 15 MINS AFTER TREATMENT BEGAN, THE NURSE CHECKED THE DIALYZER, THERE WAS NO EXACT LEAKING SPOT BUT DIALYSATE TURNED RED. UNABLE TO RETURN THE PATIENT'S BLOOD, NURSE CHANGED TO A NEW DIALYZER. NO FURTHER ISSUES OCCURRED. QB 250 ML/MIN, QD 500 ML/MIN, TMP 0MMHG, CONVECTION TARGET - 30L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423324 NIPRO ELISIO H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-19H 24K04P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention