BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 22853633 · Received August 20, 2025

    Report

    Report Number
    3014732157-2025-00899
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 17, 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
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "IV PUMP WAS RUNNING PLATELETS AND BEEPED STATING THERE WAS AN UPSTREAM OCCLUSION. RN MADE SURE THERE WERE NO CLAMPS OR KINKS ABOVE THE PUMP AND NOTICED THE PLATELET DRIP CHAMBER WAS COLLAPSED SLIGHTLY INWARD. PLATELETS WERE DOWN INTO THE DRIP CHAMBER. RN PROGRAMED PUMP TO FLUSH WITH IV FLUIDS." INJURY/ADVERSE REACTION: NO. ACTIVE INFUSION STOPPAGE: NO. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET BREAKS (ANY PART) 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

    NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. AN UPSTREAM OCCLUSION ALARM IS TRIGGERED WHEN THE LVP CANNOT FILL THE IPC (PUMPING CHAMBER) OF THE ADMINISTRATION SET DUE TO THE INLET TUBING OF THE SET BEING KINKED OR THE SLIDE CLAMP BEING ACTUATED ON THE TUBING. SMALL SYRINGES CAN SOMETIMES CAUSE THIS TO TRIGGER WHEN INFUSING FROM THE SECONDARY ACCESS PORT (THROUGH THE SECONDARY LAV). SPIKE WAS NOT INSERTED CORRECTLY INTO THE SOLUTION BAG. IF AN ADMINISTRATION SET TRIGGERS THIS ALARM WITHOUT THE TUBING BEING KINKED/CLAMPED OR WITHOUT INFUSING THROUGH A SMALL SYRINGE (5 CC), THERE COULD BE AN ISSUE WITH THE ADMINISTRATION SET THAT NEEDS TO BE INVESTIGATED. HOWEVER, NO SAMPLE WAS AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED FAILURE COULD NOT BE REPLICATED AND EXACT ROOT CAUSE COULD NOT BE PROVIDED. 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 RELATED TO KINKS 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
    1154642 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