BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058368 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01002
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    December 14, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: ADMINISTRATION SET LEAKED "BELOW" THE DRIP CHAMBER, ABOVE THE PUMP. PUMP WAS INFUSING D5W. NO PATIENT HARM. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. A SAMPLE WAS RETURNED FOR EVALUATION. THE CUSTOMER COMPLAINT WAS ABLE TO BE REPLICATED BY FILLING BAG WITH WATER AND OBSERVE SLOW LEAK FROM DRIP CHAMBER TUBING GLUE BOND. TRIED PULLING TUBING OUT OF DRIP CHAMBER TO TEST FOR WEAK BOND BUT IT HELD TOGETHER. 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
    1398644 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