BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058364 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01006
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    February 21, 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: SET WAS LEAKING OUT THE BACK OF THE CASSETTE. THE NURSE HAD TO TAKE OUT TUBING AND EXCHANGE. IT WAS INFUSING ON A PATIENT. NO HARM TO PATIENT. INFUSING NORMAL SALINE - NO MEDICATION. A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. DURING THE VISUAL INSPECTION THE SET WAS OBSERVED TO BE ASSEMBLED CORRECTLY ACCORDING TO THE APPLICABLE DRAWING. PRIMARY LINE INFUSION DID NOT PASS SUCCESSFULLY AND WAS TESTED WITH A SET RATE OF 0.5ML/HR AND SET VOLUME OF 1.5ML. A LEAK COMING FROM INSIDE OF THE CASSETTE WAS OBSERVED AND ALARM TUBING SET PROBLEM WAS REPLICATED FOUR TIMES IN THE IVENIX INFUSION MACHINE. AIR SIDE UNDER WATER LEAK TEST WAS PERFORMED AND BUBBLES WERE OBSERVED COMING FROM UNIT. LIQUID SIDE UNDERWATER LEAK TEST WAS PERFORMED, AND BUBBLES WERE OBSERVED COMING FROM UNIT. THEREFORE, LEAK WAS CONFIRMED IN BOTH UNDER WATER LEAK TESTS. A DYE TEST WAS PERFORMED, AND IT WAS OBSERVED THAT THE LEAK WAS COMING POSSIBLY COMING FROM THE SECONDARY VALVE. THE CUSTOMER COMPLAINT IS CONFIRMED. 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. IN ADDITION, IT COULD BE RELATED TO AN INCORRECT AND POOR SEALING OF THE CASSETTE IN THE WELDER MACHINE CAUSING THE GAP AND REPORTED LEAKAGE. CURRENT CONTROLS INCLUDE 100% LEAK TESTING PERFORMED BY A LEAK TESTER AND 100% VISUAL INSPECTION OF THE UNIT AT MANUFACTURING LINES. THE BATCH RECORD FA23E17360 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING. (B)(6) 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
    1398640 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 FA23E17360 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown