BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INFUSION SYSTEM

    MDR report key: 22175398 · Received June 10, 2025

    Report

    Report Number
    3014732157-2025-00628
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 29, 2025
    Report Date
    August 22, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030214
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    EVALUATION STEPS PERFORMED: 1) VISUAL INSPECTION, 2) MICROSCOPIC EVALUATION, 3) INSTALLED THE KIT ON IVENIX INFUSION SYSTEM MACHINE (SN (B)(6)) AND RAN THE PRIMARY BOLUS PRIME. 4) UNDERWATER LEAK TEST, 5) DYE TEST. ONE SAMPLES OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. OBSERVATIONS: 1) NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION AS PER DRW-SET-0032-25 / E. THE GOLD FOIL WERE AS CORRESPONDED TO THE SPECIFIC CODE SET-0032-25, 2) CAVITIES: PUMP CAVITY: 25-0177 5A, DIAPHRAGM CAVITY:2, USER SIDE CAVITY: A5, MIDDLE CAVITY: 6A, 3) MICROSCOPIC EXAMINATION REVEALED THAT THE EDGE OF THE DIAPHRAGM WAS NOT PROPERLY POSITIONED AND WAS DISPLACED TOWARDS THE FLAT AREA OF THE DIAPHRAGM, 4) PRIMARY LINE INFUSION WAS TESTED WITH A SET RATE OF 0.5ML/HR AND SET VOLUME OF 0.1ML AND PRIMARY LINE WAS CONNECTED TO A SALINE SOLUTION BAG. ALARM "TUBING SET PROBLEM" WAS OBSERVED IN THE IVENIX LVP DISPLAY. IT WAS NOT POSSIBLE TO COMPLETE THE PRIMING PROCESS, AND IT DID NOT PASS SUCCESSFULLY, 5) AN UNDERWATER LEAK TEST WAS PERFORMED TO VERIFY THE LIQUID AND AIR SIDE AREAS OF CASSETTE AND BUBBLES WERE OBSERVED COMING FROM UNIT, LOCATED AT THE LEFT SIDE OF THE CASSETTE. NO LEAKS WERE DETECTED AT THE Y-PORTS, 6)FINALLY, A DYE TEST WAS PERFORMED, AND IT WAS DETECTED THAT THE LEAK WAS LOCATED AT THE VENT HOLE NEAR THE OUTLET VALVE. CUSTOMER COMPLAINT IS CONFIRMED. THE PROBABLE ROOT CAUSE RELATED TO MANUFACTURING ERROR DURING THE POSITIONING OF THE DIAPHRAGM, LEADING TO IT BEING DISPLACED. THE CURRENT PROCESS CONTROLS DETECTION: 1) 100% LEAK AND OCCLUSION TEST IS PERFORMED THROUGH THE LEAK AND OCCLUSION TEST MACHINE IN ORDER TO CAPTURE UNITS WITH ANY BLOCKAGE OR LEAK FAILURE MODE, 2) QUALITY SAMPLING FOR FINAL PHYSICAL TESTING, FOR PERFORMING A FLOW AND UNDERWATER LEAK TESTS, 3)100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS. THE BATCH REVIEW COULD NOT BE PERFORMED AS THE AFFECTED BATCH WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: LEAKING AT PORTS. LIPIDS RUNNING. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). AN ACTIVE INFUSION WAS STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354616 IVENIX, INFUSION SYSTEM LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, DUAL FPA FRESENIUS KABI USA LLC SET-0032-01 00811505030214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown