BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INFUSION SYSTEM

    MDR report key: 22739530 · Received August 7, 2025

    Report

    Report Number
    3014732157-2025-00848
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 31, 2025
    Report Date
    October 6, 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

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "NURSE PRIMED TUBING AND WAS READY TO CONNECT TO PATIENT WHEN REALIZED THE TUBING HAD FALLEN APART AT THE Y-SITE - WE CHECKED A FEW OTHER SETS FROM SAME LOT# AND THEY APPEARED TO BE SECURE AT THE Y-SITE. INJURY/ADVERSE REACTION: NO. INFUSION STOPPAGE: NO. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: BROKEN SET. AN ACTIVE INFUSION WAS NOT STOPPED. REPORTING AS A CONSERVATIVE MEASURE. NO ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 0

    EVALUATION STEPS PERFORMED: 1. VISUAL INSPECTION. 2. MICROSCOPIC EVALUATION. OBSERVATIONS: (01) ONE SAMPLES OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION AS PER DRAWINGS. THE GOLD FOIL WERE AS CORRESPONDED TO THE SPECIFIC CODE SET-0032-25. CAVITIES: PUMP CAVITY: 25-0177 5A, DIAPHRAGM CAVITY:2, USER SIDE CAVITY: A8, MIDDLE CAVITY: 8A. DURING THE INSPECTION A DETACHED Y-SITE (NEEDLE-FREE ACCESS PORT) WAS FOUND FROM THE TUBING. THE SEPARATED Y-SITE WAS RETURNED FOR EVALUATION. FEW TRACES OF SOLVENT WERE OBSERVED AT THE TUBING AND THE NEEDLE-FREE ACCESS PORT. CUSTOMER COMPLAINT IS CONFIRMED. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED INCIDENT IS RELATED TO THE LACK OF SOLVENT APPLICATION DURING THE MANUFACTURING PROCESS. THE OPERATOR DID NOT PERFORM THE JOINING OPERATION CORRECTLY. CURRENT PROCESS CONTROLS DETECTION: -POST STERILIZATION SAMPLING FINAL INSPECTION. -100% VISUAL INSPECTION RELATED TO SEPARATED COMPONENTS DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS -THE FIRST PIECE INSPECTION WILL BE PERFORMED TO THE FIRST FINAL ASSEMBLED KIT MANUFACTURED PER SHIFT. THIS KIT WILL BE SUBMITTED TO VISUAL INSPECTION AS PER THE CLASSIFICATION OF DEFECTS INCLUDED IN THIS SPECIFICATION AND AS PER THE APPLICABLE DRAWING. CODE NO.: SET-0032-25. BATCH NO.: FA25A27135. EXCEPTION GENERATED: THE BATCH RECORD FA25A27135 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. QUALITY TEST RESULTS: THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504907 IVENIX, INFUSION SYSTEM LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, DUAL FPA FRESENIUS KABI USA LLC SET-0032-01 FA25A27135 00811505030214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown