BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 20835835 · Received December 3, 2024

    Report

    Report Number
    3014732157-2024-00850
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 23, 2025
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FRN
    UDI-DI
    00811505030320
    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

    CORRECTION TO INITIAL MDR: THE BIOMED REPORTED THE PUMP WOULD NOT RECOGNIZE CASSETTES. AT THE TIME OF INITIAL MDR SUBMISSION, NO LOG FILES WERE RECEIVED FROM THE CUSTOMER. SINCE THEN, LOG FILES HAVE BEEN RECEIVED AND A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: PNEUMATIC VALVE LEAK FAILURE (VALVE 3). THE DEVICE WAS RETURNED FOR INVESTIGATION. AFTER DEVICE WAS POWERED ON AND A CASSETTE WAS INSERTED, A TUBING SET ALARM WOULD OCCUR. THE DEVICE WAS OPENED TO INSPECT FOR DAMAGE AND CONNECTION INTEGRITY. THE PNEUMATIC SYSTEM WAS REMOVED AND TESTS WERE RUN ON THE MANIFOLD. THE MANIFOLD WAS ABLE TO PASS TESTING WITH NO FAILURES. THEREFORE, THE PNEUMATIC VALVE LEAK FAILURE WAS NOT CONFIRMED. FURTHER INSPECTION FOUND DRIED FLUID INGRESS AROUND THE SET ID. THE FOAM SEAL SURROUNDING THE PCB FOR THE SET ID HAD A PIECE OF PLASTIC FROM THE FRONT HOUSING STUCK TO IT. BECAUSE OF THIS PLASTIC INTRUSION, THE INTEGRITY OF THE SEAL WAS COMPROMISED AND FLUID WORKED ITS WAY INTO THE DEVICE. IT IS POSSIBLE THIS FAILURE OCCURRED DUE TO A MANUFACTURING ASSEMBLY ERROR.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTS: THIS GUY WILL RECOGNIZE CASSETTES. NO PT HARM OR INFUSION STOPPAGE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: FAIL STOP, CAUSE UNKNOWN. 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
    1414289 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown