BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058355 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01000
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 26, 2022
    Report Date
    September 15, 2025
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    UDI-DI
    00811505030054
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: THIS INCIDENT HAPPENED PRIOR TO BEGINNING TREATMENT WHEN THE TUBING WAS ALREADY INSERTED AND WATER WAS COMING OUT OF THE MACHINE. THE DOOR WAS OPENED TO CHECK IF IT WAS PROPERLY LOADED. THE TUBING WAS LOADED PROPERLY, BUT THE WATER WAS STILL COMING OUT OF THE PUMP. SO, THE NURSE HAD TO GET ANOTHER ADMINISTRATION SET. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. THE DEVICE WAS RETURNED FOR EVALUATION. ADMIN SET DIAPHRAGM NOT FULLY CAPTURED BY THE ADMIN SET SHELL AND ISN'T FULLY SEALING THE FLUID FLOW PATH. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398631 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown