BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058363 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01008
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    March 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: LEAKING FROM THE SECONDARY INLET PORT. THE NURSE STATES SHE WAS ABLE TO "UNSCREW" THE PORT FROM THE SET. SHE TRIED TO SCREW IT BACK ON WITH HEMOSTATS BUT IT CONTINUED TO LEAK. THE LEAKING SET WAS REPLACED BY ANOTHER SET WITHOUT INCIDENCE. THE SET WAS NOT INFUSING HAZARDOUS DRUG AND IS BEING SENT IN FOR FURTHER EVALUATION. NO PATIENT HARM. NO DELAY IN INFUSION THERAPY. THE NURSE TOOK IT UPON HERSELF TO SEE IF SHE COULD REMOVE ANY ADDITIONAL PORTS FROM SETS FROM THE SAME LOT NUMBER. SHE REPORTS SHE COULD REMOVE A SECONDARY INLET PORT WITH FORCE AIDED BY HEMOSTATS. 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. SECONDARY PORT WAS MANUALLY SCREWED ON SET AND PRIMARY LINE INFUSION WAS TESTED AND 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 TWICE IN THE IVENIX INFUSION MACHINE. IT WAS NOT POSSIBLE TO PERFORM THE AIR SIDE AND LIQUID SIDE UNDER WATER LEAK TESTS AS THE SECONDARY PORT WAS NOT ASSEMBLED CORRECTLY ON THE SET. IT WAS NOT POSSIBLE EITHER TO PERFORM THE DYE TEST FOR THE SAME REASON. THE CUSTOMER COMPLAINT IS CONFIRMED. HOWEVER, IT WAS NOT POSSIBLE TO DETECT THE SOURCE OF THE LEAKAGE. 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. REGARDING THE LEAK INSIDE OF THE CASSETTE FOUND DURING THE SAMPLE EVALUATION COULD BE RELATED TO AN IMPROPER SEALING OF THE CASSETTE IN THE WELDER MACHINE AT THE SUPPLIER FACILITY. 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
    1398639 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA, LLC SET-0013-1 3009776 00811505030054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown