BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23468803 · Received November 4, 2025

    Report

    Report Number
    3015537318-2025-00100
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 4, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    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. AS PREVIOUSLY MENTIONED INTERA ONCOLOGY COMMUNICATED WITH THE PHYSICIAN, AND HE STATED EVERYTHING IS RESOLVED. THE PATIENT'S IRON INFUSION WAS THE CAUSED FOR THE SPIKE IN LIVER FUNCTION TESTS, WHICH IS UNRELATED TO THE PUMP.

    Description of Event or Problem · 0

    AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS IMPLANTED TO A PATIENT ON (B)(6) 2025, AND THE PATIENT STARTED FLOXURIDINE AT WEEK 6 POST OP. THE PATIENT HAD 3 CYCLES OF FLOXURIDINE, LAST BEING ON (B)(6) 2025. THE PUMP WAS REFILLED WITH HEP/SALINE + 20 MG DEXAMETHASONE (DEX) ON (B)(6) 2025. OUR REPRESENTATIVE RECEIVED AN EMAIL FROM THE PHYSICIAN NOTING THE PATIENT PRESENTED TO EMERGENCY ROOM WITH NAUSEA FOR 6 DAYS AND PROGRESSIVE FATIGUE. THE PHYSICIAN FELT THE PATIENT WAS LIKELY TO PRESENT WITH EITHER GASTRITIS, DUODENITIS OR OBSTRUCTION UNRELATED TO PUMP BUT REQUESTED INFORMATION ON ANY OTHER POTENTIAL DIFFERENTIALS RELATED TO PUMP. THE PATIENT'S CT SCAN AND LABS WERE WITHIN NORMAL LIMITS (WNL). THEN ON OCTOBER 6, 2025, OUR REPRESENTATIVE RECEIVED A FOLLOW UP EMAIL FROM THE PHYSICIAN THAT THE LIVER FUNCTION TESTS (LFTS) "SKYROCKETED TO THE 1000S". THE CT ANGIOGRAPHY SHOWED NO SIGNS OF ARTERIAL DISSECTION/THROMBUS. THE PORTAL VEIN ULTRASOUND WAS WITH NORMAL PORTAL FLOW. THE CLINIC PLANNED IN DOING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). INTERA ONCOLOGY COMMUNICATED WITH THE PHYSICIAN, AND HE STATED EVERYTHING IS RESOLVED. THE PATIENT'S IRON INFUSION WAS THE CAUSED FOR THE SPIKE IN LIVER FUNCTION TESTS, WHICH IS UNRELATED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254382 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30402081 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention| O| H FLOXURIDINE FOR INJECTION, USP 500 MG/VIAL.