BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23480215 · Received November 5, 2025

    Report

    Report Number
    3015537318-2025-00103
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 5, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    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. INTERA ONCOLOGY HAS REACHED OUT TO THE PHYSICIAN MULTIPLE TIMES TO OBTAIN INFORMATION WITH NO SUCCESS. THE EXACT ROOT CAUSE OF WHY THE PUMP FLIPPED IS UNKNOWN. HOWEVER, DEVICE MIGRATION IS A KNOWN ADVERSE EVENT LISTED ON THE LABELING OF THE INTERA 3000 PUMP AND INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT ON (B)(6) 2025, THEY WERE UNABLE TO EMPTY AND REFILL AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP. ON (B)(6) 2025, THE PATIENT WAS SENT TO (B)(6) INSTITUTE, AND THEY WERE ALSO UNABLE TO ACCESS THE PUMP. THE PATIENT WAS SENT TO (B)(6) FOR A CT SCAN THAT SHOWED THE PUMP HAD FLIPPED OVER. THE PATIENT WAS TAKEN TO SURGERY, AND THE PUMP WAS FLIPPED BACK OVER AND SECURED TO THE FASCIA. THE PUMP WAS REFILLED AT THIS TIME WITH 30MLS HIGH DOSE HEPARINIZED SALINE (1000 UNITS/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678113 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30555095 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention