BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVENIX LARGE VOLUME INFUSION PUMP

    MDR report key: 20033768 · Received August 22, 2024

    Report

    Report Number
    3014732157-2024-00580
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 3, 2024
    Report Date
    September 24, 2024
    Manufacturer
    FRESENIUS KABI USA LLC
    Product Code
    FRN
    PMA / PMN Number
    K183311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    TTHE PUMP WAS FLAGGED FOR A VALVE 2 LEAK. THE PUMP WAS RETURNED FOR INVESTIGATION. THE PUMP HAD ITS SOFTWARE UPDATED TO NEW VERSION. PUMP WAS ABLE TO RUN FINAL ACCEPTANCE TEST AND WAS REVERTED TO MANUFACTURING MODE TO TEST FUNCTIONALITY OF PNEUMATICS. FUNCTIONALITY TESTING WAS PASSED. UPDATED SOFTWARE HAS FIXED MOST PROBLEMS OF LEAKS INCLUDING THIS PUMP. PUMP WILL BE SENT TO REPAIR FOR ALL FUNCTIONAL TESTING. ONCE THE PUMP HAS SUCCESSFULLY PASSED ALL NECESSARY FUNCTIONAL TESTING, IT WILL BE REVIEWED FOR QUALITY RELEASE. THE COMPLAINT WAS NOT CONFIRMED BECAUSE THE PUMP HAD SOFTWARE UPDATED THAT FIXED ISSUE.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: PUMP: (B)(6) ON (B)(6) 2024 WE NEED TO CHECK FOR OVER INFUSION, SET ISSUES, AND PUMP ISSUES CASSETTE LOT# 3010943 SERVICE NEEDED ALARM NO PATIENT HARM REPORTED. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: PNEUMATIC VALVE LEAK FAILURE (VALVE 2) 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
    28667 IVENIX LARGE VOLUME INFUSION PUMP INFUSION PUMP SYSTEM FRN FRESENIUS KABI USA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown