BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX INFUSION SYSTEM

    MDR report key: 20577943 · Received October 31, 2024

    Report

    Report Number
    3014732157-2024-00786
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 10, 2024
    Report Date
    January 7, 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

    3 REQUESTS WERE MADE TO HAVE THE PUMP RETURNED WITH NO RESPONSE FROM THE CUSTOMER. SINCE THE PUMP WAS NOT PROVIDED, THE PUMP PROBLEM IS UNKNOWN. NO ACTIONS AT THIS TIME SINCE THE LOGS WERE NOT PROVIDED, THE PUMP PROBLEM IS UNKNOWN, AND DUE DILIGENCE HAS BEEN COMPLETED.

    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. 10/16/24 - BIOMED EMAILED SERIAL #, REPORTED: SHUT OFF DURING INFUSION. PUMP STATED NEEDED UPDATE AND THEN SHUT ITSELF OFF. ATTEMPTED TO RESTART AND REUSE, WORKED FOR ABOUT 1 HR AND DID THE SAME THING AGAIN. UNABLE TO DUPLICATE, CLEANED AND RUN TEST PATIENT WITHOUT ISSUE. RETURNED TO THE FLOOR. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: INFUSION STOPPED 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
    1804570 IVENIX INFUSION SYSTEM LARGE VOLUME PUMP (LVP) FRN FRESENIUS KABI USA LLC LVP-0004 00811505030320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown