BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIPRO CELLENTIA 21H DIALYZER

    MDR report key: 19475478 · Received June 6, 2024

    Report

    Report Number
    19475478
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    February 6, 2024
    Report Date
    February 7, 2024
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER BEING PRIMED, THE DIALYZER CELLENTIA 21H FILLED HALFWAY WITH BLOOD. MACHINE WAS STOPPED. UNABLE TO RETURN BLOOD TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861863 NIPRO CELLENTIA 21H DIALYZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO MEDICAL CORPORATION DD+CT21H 23128E

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female