BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 20953822 · Received December 17, 2024

    Report

    Report Number
    3014732157-2024-00889
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 5, 2024
    Report Date
    February 5, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NO SAMPLE OR PICTURE WAS AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IT IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE POTENTIAL ROOT CAUSES OF THE LEAK IN CASSETTE COULD BE RELATED TO 1) MISPLACED DIAPHRAGM WHICH RESULTED IN A LEAK WHEN THE DIAPHRAGM WAS ACTUATED BY THE VALVE PINS IN THE PUMP, 2) AN INCORRECT AND POOR SEALING OF THE CASSETTE IN THE WELDER MACHINE CAUSING THE REPORTED LEAKAGE. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES 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.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: ON (B)(6) 2024 WE HAD AN ISSUE WITH THE IVENIX PRIMARY TUBING. SET-0013-1, LOT 3010653. IT HAD A HOLE IN THE SILICONE DOME OF THE CASSETTE, IT WAS PRIMED WITH NS AND THE LEAK WAS DISCOVERED. THE TUBING WAS DISCARDED BY THE EMPLOYEE (THEY HAVE BEEN REMINDED TO KEEP THIS NEXT TIME). A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) UNKNOWN IF 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
    266317 IVENIX, INC. LVP PRIMARY ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, NEEDLE-FREE PORT, Y-SIT FPA FRESENIUS KABI USA LLC SET-0013-01 3010653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown