BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058851 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01015
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    June 13, 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
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: THE PATIENT STATED THAT SHE WAS SITTING IN HER CHAIR WHEN SHE REALIZED THAT SUDDENLY IT WAS "RAINING". NO CHEMO CAME INTO DIRECT CONTACT WITH THE PATIENT. BUT THE SPILL WAS DESCRIBED AS VERY LARGE BY THE PRIMARY NURSE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. A VIDEO WAS PROVIDED BY THE CUSTOMER WHICH CONFIRMED THE REPORTED ISSUE. PROBABLE ROOT CAUSE OF REPORTED FAILURE COULD BE RELATED TO THE SUPPLIER MANUFACTURING PROCESS. IT IS POSSIBLE THAT A LEAK WAS DUE TO A LOOSE SECONDARY PORT CAUSED BY THE TIP OF K-ZERO NEEDLE-FREE LUER ACTIVATED VALVE BEING BROKEN CAUSING IT TO DETACH FROM THE SECONDARY PORT BASED ON PREVIOUS COMPLAINTS RECEIVED. A QUALITY ALERT WAS ISSUED TO THE PRODUCTION FLOOR TO PROVIDE OPERATOR AWARENESS OF THIS COMPLAINT AND REINFORCE CURRENT WORK INSTRUCTION AT THE SUPPLIER. 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
    1720991 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 3010127 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown