BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23058855 · Received September 15, 2025

    Report

    Report Number
    3014732157-2025-01003
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    July 31, 2023
    Report Date
    September 15, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BLOOD HAD EXPLODED FROM THE CASSETTE WHILE LOADED IN THE DEVICE A PRELIMINARY REVIEW OF THE LOGS COULD NOT BE PERFORMED. NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. THEREFORE, THE CUSTOMER REPORTED ISSUE COULD NOT BE CONFIRMED. PROBABLE ROOT CAUSE COULD BE RELATED TO AIR BUBBLES INSIDE THE ADMINISTRATION WHICH WERE NOT ELIMINATED DUE TO THE ADMINISTRATION SET WAS NOT PRIMED PROPERLY. THE LVP DOES NOT "AUTO PRIME" THE PRIMARY LINE. BASED ON THE QUICK REFERENCE GUIDE, THE USER MUST ALLOW FLUIDS TO WARM TO ROOM TEMPERATURE BEFORE PRIMING AND INFUSING. OTHERWISE, THE FORMATION OF BUBBLES (OUTGASSING) MAY OCCUR AND CAUSE AIR-IN-LINE ALARMS. USER ALSO MUST ADD A CHECK VALVE TO DECREASE THE BUILD-UP OF AIR BUBBLES AND REDUCE AIR-IN-LINE ALARMS BY KEEPING THE FLUID PRESSURIZED DURING THE INFUSION. ANOTHER PROBABLE ROOT CAUSE COULD BE RELATED TO A LEAK LOCATED SOMEWHERE IN THE KIT. WITHOUT THE SAMPLE IT IS NOT POSSIBLE TO DETERMINE THE EXACT LOCATION OF THE LEAK. CURRENT CONTROLS INCLUDE 100% LEAK TESTING PERFORMED BY A LEAK TESTER AND 100% VISUAL INSPECTION OF THE UNIT AT MANUFACTURING LINES. 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
    1720995 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