BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX, INC.

    MDR report key: 23417264 · Received October 29, 2025

    Report

    Report Number
    3014732157-2025-01185
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 24, 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
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ONE SAMPLE OF IVENIX ADMINISTRATION SET WAS RETURNED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE GOLD FOIL CORRESPONDED TO THE SPECIFIC CODE SET-0014-20. THE SET WAS INSTALLED ON THE LVP, AND THE DEVICE WAS SUCCESSFULLY RECOGNIZED WITHOUT ANY ISSUES. A PRIMARY LINE INFUSION TEST WAS INITIATED, AND THE LVP SHOWED NO ALARM SIGNALS. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVALUATION METHODS APPLIED TO THE RETURNED SAMPLE WERE NOT ABLE TO IDENTIFY THE ORIGIN OF THE REPORTED DEFECT (TUBING NOT RECOGNIZED ALARM). NO VISIBLE DEFECTS WERE OBSERVED IN THE UNIT, AND NO CONCLUSIVE EVIDENCE WAS FOUND TO EXPLAIN THE ISSUE REPORTED. THE CURRENT PROCESS CONTROLS DETECTION INCLUDES VISUAL INSPECTION OF GOLD FOIL STAMP, 100% VISUAL INSPECTION DURING THE MANUFACTURING PROCESS AND FINAL PHYSICAL INSPECTIONS, POST STERILIZATION SAMPLING FINAL INSPECTION, 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, 5) 100% VISUAL INSPECTION IS PERFORMED IN MANUFACTURING LINE. THE BATCH RECORD FA25E19083 WAS REVIEWED. NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS TESTING AND PRODUCT TESTING.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: "BLOOD TUBING ERROR READ "TUBING NOT RECOGNIZED" REPLACED TUBING WITH ANOTHER SET AND RECEIVED THE SAME MESSAGE AGAIN. TWO SETS WERE TRIED AND FAILED. THIRD SET WORKED FINE. WE HAD TWO BLOOD SETS FAIL UPON LOADING INTO A PUMP. TUBING NOT RECOGNIZED. TUBING HAS BEEN SAVED BUT BLOOD IN BOTH SETS SINCE BLOOD WAS SPIKED. PATIENT HARM: NO. INFUSION STOPPAGE: NO. ADDITIONAL CLARIFYING INFORMATION RECEIVED: THE TUBING WOULDN'T "READ" ON THE PUMP. THEY TRIED IT ON ANOTHER PUMP AND IT DIDN'T READ ON THAT ONE EITHER. THEY GOT A SECOND SET TRIED ON BOTH PUMPS AND IT DID NOT READ. THE THIRD SET SAME LOT/BATCH READ ON ORIGINAL PUMP. THEY DIDN'T RECORD PUMP NUMBER SINCE IT APPEARED TO BE AN IV SET PROBLEM. MORE INFORMATION IS NEEDED TO INVESTIGATE THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215408 IVENIX, INC. LVP BLOOD PRODUCTS ADMINISTRATION SET, DUAL-INLET, LOW-SORBING, Y-SITE, MESH FIL FPA FRESENIUS KABI USA, LLC SET-0014-1 FA25E19083 00811505030030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown