BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 20577957 · Received October 31, 2024

    Report

    Report Number
    3014732157-2024-00787
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 3, 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
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: BIOMED REPORTED: THE CONCERN IS HOW OFTEN THE PUMP REQUIRES A COMPLETE SHUTDOWN TO CLEAR AN ALARM. IN THE 12 MONTHS RUNNING ON 5M/N WE NEVER HAD THIS MANY PUMPS PULLED FOR SERVICE OR "SERVICE ALARMS". LOOKING THROUGH WE HAVE ABOUT 24 PULLED RIGHT NOW. JUST LOOKING FOR SOME CLARIFICATION ON WHY WE DIDN'T SEE THIS ALARM PREVIOUSLY IN THE ORIGINAL 44 PUMPS. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: INFUSION STOPPED. (B)(6) 2024 - BIOMED EMAILED SERIAL #, REPORTED: PER SCREEN PROMP " PUMP PROBLEM" " INFUSION STOPPED" SERVICE NEEDED, UNABLE TO DUPLICATE, CLEANED AND RUN TEST PATIENT WITHOUT ISSUE. RETURNED TO THE FLOOR. 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

    THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED FOR A PUMP PROBLEM ALARM. PRIOR TO THE PUMP BEING RETURNED, THE DEVICE WAS CLEANED AND TESTED BY BIOMED WITHOUT ISSUE. LOGS WERE NOT ABLE TO BE RETRIEVED UNTIL THE DEVICE WAS AT THE EVALUATION FACILITY. PUMP PASSED MOCK INFUSION TESTING DURING INVESTIGATION. LOG FILES PULLED FROM THE DEVICE SHOW A VALVE MOTOR FAILURE OCCURRED PRIOR TO THE DEVICE BEING CLEANED AND TESTED BY BIOMED. INTERNAL INSPECTION OF DEVICE FOR DAMAGE FOUND NONE. THE FVA PINS SHOULD BE CLEANED AND THEIR LIP SEALS SHOULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067029 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown