BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058357 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01004
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    December 20, 2023
    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
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: TONIGHT, WE HAD A PATIENT ON A CHEMO REGIMEN AND THE NURSE REPORTED LEAKING FROM THE CASSETTE THAT IS IN THE PRIMARY TUBING. THE DRUG HAD BEEN RUNNING FOR A SHORT TIME 2HRS WHEN IT WAS DISCOVERED AND THE NURSE REPORTS AN ESTIMATED 3 DROPS OF LEAKAGE SEEN BUT COULD HAVE BEEN MORE AS THE PATIENT WAS MOVING AROUND. WE DID STOP THE DRIP RE-MIX AND GIVE THEM A NEW BAG TO HANG AS WE COULD NOT BE SURE IF STERILITY WAS COMPROMISED. THE REGIMEN IS A COMBINATION BAG OF ETOPOSIDE/DOXORUBICIN/VINCRISTINE THAT RUNS CONTINUOUSLY OVER 24HRS FOR 5 DAYS. THE PATIENT WAS STARTED ON THE REGIMEN ON (B)(6) 2023 AND TODAY IS THE 3RD DAY OF THERAPY SO 3RD BAG TO BE HUNG. EARLIER TODAY WITH THE 2ND BAG THAT HAD BEEN RUNNING WE ALSO DID HAVE SOME LEAKING FROM THE FILTER WHICH WAS SEPARATE SITE. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLES OR PICTURES AVAILABLE FOR EVALUATION. THEREFORE, IT IS NOT POSSIBLE TO REPLICATE OR CONFIRM THE REPORTED ISSUE. THE LEAK IN CASSETTE COULD BE POTENTIALLY RELATED TO A MISPLACED DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP. THE IN-PROCESS LEAK TESTING PROCESS FAILED TO DETECT THE LEAK AT MANUFACTURING FACILITY. CURRENT CONTROLS INCLUDE 100% LEAK TESTING PERFORMED BY A LEAK TESTER AND 100% VISUAL INSPECTION OF THE UNIT AT MANUFACTURING LINES. 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
    1398633 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