BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058353 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01010
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    April 19, 2024
    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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: A SET WAS REPORTED TO LEAK FROM THE SECONDARY INLET PORT DURING PRIMING. THE CONNECTOR WAS REPORTED TO BE "VERY LOOSE AND CAME OFF." THERE WAS NO PATIENT HARM AND NO DELAY IN INFUSION. THERE WAS NO HAZARDOUS MATERIALS IN THE SET. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE SECONDARY PORT WAS SEPARATED FROM THE SET AS REPORTED BY THE CUSTOMER. IT WAS NOT POSSIBLE TO INSTALL THE UNIT INTO THE IVENIX MACHINE AS THE SECONDARY PORT WAS LOOSE AND SEPARATED FROM PORT. THE CUSTOMER COMPLAINT IS CONFIRMED. PROBABLE ROOT CAUSE OF REPORTED FAILURE COULD BE RELATED TO THE SUPPLIER MANUFACTURING PROCESS. IT IS POSSIBLE THAT THE SECONDARY PORT WAS NOT ASSEMBLED CORRECTLY CAUSING THE UNIT TO BE SEPARATED FROM CASSETTE. THE SUPPLIER OPENED A COMPLAINT TO INVESTIGATE THIS ISSUE. 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
    1397698 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 3009778 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown