BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23303788 · Received October 15, 2025

    Report

    Report Number
    3015537318-2025-00093
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 9, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE EXACT ROOT CAUSES OF WHY THE PUMP FLIPPED IS UNKNOWN. HOWEVER, DEVICE MIGRATION IS A KNOWN ADVERSE EVENT ON THE LABELING OF THE INTERA 3000 PUMP.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A NURSE ABOUT THEM BEING UNABLE TO ACCESS AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP. AFTER MULTIPLE ATTEMPTS TO ACCESS THE PUMP, THE CLINIC BELIEVED THE PUMP FLIPPED. AN X-RAY WAS DONE AND CONFIRMED THE PUMP FLIPPED. ON (B)(6) 2025, THE PATIENT WAS SEEN, AND THE PHYSICIAN WAS ABLE TO MANUALLY MANIPULATE THE PUMP AND FLIP IT BACK OVER. ONE OF THE NURSES WAS SUCCESSFUL AT ACCESSING THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338662 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 29352421 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female