BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23623718 · Received November 21, 2025

    Report

    Report Number
    3015537318-2025-00110
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 21, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THEREFORE, THE ROOT CAUSE OF THIS INCIDENT IS USE ERROR DUE TO CHEMOTHERAPY BEING DEPOSITED INTO SURROUNDING TISSUE RATHER THAN THE PUMP RESERVOIR, RESULTING IN LOCALIZED INFLAMMATORY AND CHEMICAL IRRITATION. THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP INSTRUCTION FOR USE PROVIDES DETAILED INSTRUCTIONS FOR PUMP REFILL PROCEDURES AND HOW TO PROPERLY POSITION THE NEEDLE TO THE PUMP SEPTUM. IN ADDITION, SEROMA IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP INSTRUCTION FOR USE AND LABELING.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN THAT A PUMP REFILL OF FLOXURIDINE DONE ON (B)(6) 2025, HAD THE PATIENT DEVELOPED SHARP GASTRIC PAIN WITHIN FIVE DAYS (OCTOBER 20, 2025), WITH NEW ONSET ACUTE LOCALIZED PERI-PUMP SWELLING REPORTED BY PATIENT ON (B)(6), 2025, THE PATIENT WAS SENT TO THE SURGEON. THE SURGEON FOUND THE PATIENT TO HAVE LOCALIZED PUMP POCKET SWELLING WITH A FLUID COLLECTION, WITH 40+ CC ASPIRATED. THE SURGEON DETERMINED THIS TO BE A PUMP ACCESS ISSUE AND FOUND THAT INFUSATE WAS INJECTED INTO PUMP POCKET RATHER THAN RESERVOIR. THE PATIENT WAS PUT UNDER OBSERVATION; NO INTERVENTION PLANNED. THE SURGEON DOES NOT SUSPECT MECHANICAL OR PUMP/CATHETER JUNCTIONAL LEAK. ADDITIONALLY, ON (B)(6) 2025, CT IMAGING CONFIRMED CATHETER TIP IS IN PROPER POSITION, NO PUMP OR CATHETER ABNORMALITIES WERE OBSERVED. ALSO, IT FOUND A SMALL AMOUNT OF ASCITES AND MILD NODAL INCREASE, RAISING A CONCERN FOR CARCINOMATOSIS. ON (B)(6) 2025, THE PATIENT HAD HEP SALINE REFILL WHICH THE RESIDUAL VOLUME WAS 15 CC. THE LIVER FUNCTION TEST (LFT) WAS ELEVATED AT THE TIME, THE PHYSICIAN FELT TO BE RELATED TO PRIOR FLOXURIDINE. NO REPORTS OF RECURRENT LOCALIZED PUMP POCKET SWELLING AT THE TIME. ON NOVEMBER 11, 2025, THE PHYSICIAN INFORMED OUR REPRESENTATIVE THAT THE RECURRENT FLUID COLLECTION IS NO LONGER SUSPECTED TO BE RELATED TO THE PUMP OR EXTRAVASATION, BUT RATHER SUDDEN-ONSET MALIGNANT ASCITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304060 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30146270 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other| R FLOXURIDINE FUDR NDC 81643-9270-1 STRENGTH 500 MG