BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 22882939 · Received August 25, 2025

    Report

    Report Number
    3014732157-2025-00910
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 11, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FPA
    UDI-DI
    00811505030030
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "PATIENT RECEIVING PRBC, INFUSION CLOSE TO COMPLETION WHEN BLOOD STARTED LEAKING OUT OF FLOW DIAL AND DOWN TUBING AND ONTO FLOOR. RN ATTEMPTED TO DRAW BLOOD INTO SYRINGE TO MANUALLY INJECT AND IT WOULD ONLY SUCK AIR FROM DIAL. " "INFUSION STOPPED, PUMP CLEANED. " PATIENT HARM: NO ACTIVE INFUSION STOPPAGE: YES DRUG: PRBC. 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.

    Description of Event or Problem · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. A PICTURE WAS PROVIDED BY THE CUSTOMER. THE PICTURE CONFIRMED THE LEAK REPORTED FROM THE FLOW DIAL. 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, 3) CASSETTE SEAL NOT ASSEMBLED CORRECTLY CAUSING A LEAK IN THE FLOW DIAL. AN INTERNAL INVESTIGATION WAS OPENED TO ADDRESS THIS ISSUE. THE CURRENT PROCESS CONTROLS DETECTION INCLUDE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335329 IVENIX, INC. LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL FPA FRESENIUS KABI USA LLC SET-0014-1 00811505030030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown