BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058850 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01007
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    February 13, 2024
    Report Date
    September 15, 2025
    Manufacturer
    FRESENIUS KABI USA, LLC
    Product Code
    FPA
    UDI-DI
    00811505030030
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BLOOD TUBING THAT HAD THE CASSETTE BREAK AND START LEAKING OUT BLOOD DURING ADMINISTRATION. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. THEREFORE, THE CUSTOMER REPORTED ISSUE COULD NOT BE CONFIRMED. POTENTIAL ROOT CAUSE COULD BE RELATED TO AN IMPROPER HANDLING ONE OF THE ADMIN SET TUBES, BEING ABLE TO GET IN CONTACT WITH SHARP SURFACE AND CAUSED LEAKAGE. A LEAK IN CASSETTE POTENTIALLY CAUSED BY A MISPLACEMENT OF THE DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP. A LEAK IN CASSETTE POTENTIALLY CAUSED DUE TO AN INCORRECT AND POOR SEALING OF THE CASSETTE IN THE WELDER MACHINE CAUSING THE GAP AND REPORTED LEAKAGE. HOWEVER, WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. 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
    1720990 IVENIX, INC. LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL FPA FRESENIUS KABI USA, LLC SET-0014-1 00811505030030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown