BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIPRO ELISIO-H DIALYZER

    MDR report key: 25154114 · Received May 12, 2026

    Report

    Report Number
    9610987-2026-00036
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 12, 2026
    Manufacturer
    NIPRO CORPORATION (ODT)
    Product Code
    KDI
    PMA / PMN Number
    K131935
    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

    THE PATIENT IS A REGULAR OUTPATIENT UNDERGOING MAINTENANCE DIALYSIS. THE PATIENT RECEIVED HEMODIAFILTRATION (HDF) TREATMENT IN OUR DEPARTMENT DURING THE AFTERNOON SHIFT ON FEBRUARY 11. A NIPRO ELISIO-17H HEMOFILTER WAS USED FOR THE TREATMENT AS PER THE PHYSICIAN'S ORDER. AT 15:05, THE PATIENT'S VITAL SIGNS WERE STABLE, AND DIALYSIS WAS INITIATED ACCORDING TO THE ORDER.AT 15:07, THE BLOOD PRESSURE WAS 124/85 MMHG AND HEART RATE 60 BPM. THE PATIENT COMPLAINED OF NUMBNESS IN THE LEFT UPPER EXTREMITY (PUNCTURE ARM) AND PALPITATIONS WITH DISCOMFORT. IMMEDIATE INSPECTION OF THE PUNCTURE SITES SHOWED NO INFILTRATION AT EITHER THE ARTERIAL OR VENOUS ACCESS. THE DIALYZER AND BLOOD TUBING SET WERE THEN CHECKED. THE VENOUS BYPASS LINE APPEARED LIGHT RED, INDICATING DIALYZER MEMBRANE RUPTURE WITH BLOOD LEAKAGE. THE PHYSICIAN WAS NOTIFIED IMMEDIATELY. THE DIALYZER WAS REPLACED AND THE DIALYSIS MACHINE WAS CHANGED TO MACHINE G9 AS ORDERED, AND DIALYSIS WAS RESTARTED. AT 19:25, THE PATIENT COMPLETED THE HEMODIALYSIS TREATMENT AND WAS DISCONNECTED FROM THE MACHINE. THE PATIENT REPORTED NO DISCOMFORT AND LEFT THE DIALYSIS UNIT UNASSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546721 NIPRO ELISIO-H DIALYZER DIALYZER KDI NIPRO CORPORATION (ODT) ELISIO-17H 25F30H

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other| R