BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 20516922 · Received October 23, 2024

    Report

    Report Number
    3014732157-2024-00779
    Event Type
    Malfunction
    Date Received
    October 23, 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. ADDITONAL INFORMATION: BIOMED EMAILED SERIAL #, CONFIRMED NO PATIENT HARM OR REPORT OF ISSUE STOPPING ACTIVE INFUSION. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: SENSOR HARDWARE FAILURE (PRESSURE SENSOR BOARD) 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

    THE DEVICE RETURNED FOR PRESSURE SENSOR BOARD FAILURE. DEVICE WAS OPENED TO INVESTIGATE THE RATTLING NOISE HEARD. ONE OF THE SCREWS FOR THE PNEUMATIC PLATE WAS LOOSE AND MOVING AROUND IN THE DEVICE. NO OTHER PHYSICAL DAMAGE WAS FOUND. AFTER INSPECTION FOR INTERNAL DAMAGE WAS PERFORMED, DEVICE WAS PUT BACK TOGETHER AND MOCK INFUSION TESTING WAS RUN. DEVICE PASSED TESTING WITH NO FAILURES. DEVICE SPEAKER SOUNDED DISTORTED DURING TESTING. LOG FILES CONFIRM MULTIPLE PRESSURE SENSOR BOARD FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567567 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown