BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23889552 · Received December 24, 2025

    Report

    Report Number
    3015537318-2025-00120
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 24, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. HEMATOMA AND SEROMA IS A KNOWN ADVERSE EVENT LISTED IN THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP IFU AND LABEL.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT A PATIENT CALLED THE CLINIC ON (B)(6) 2025, STATING HE HAD SWELLING IN THE PUMP POCKET AREA (LLQ AREA). THE PATIENT HAD NO FEVER OR PAIN. THE PATIENT WENT TO THE EMERGENCY ROOM AFTER CALLING THE PHYSICIAN'S OFFICE. THE INITIAL THOUGHT FROM THE PHYSICIAN WAS EXTRAVASATION OF FUDR THAT WAS DONE AT THE LAST REFILL ON (B)(6) 2025. HOWEVER, THIS THOUGHT WAS LATER DISCARDED AS IT WAS REVEALED THE PATIENT HAD HEMATOMA AND NO EXTRAVASATION. IN ADDITION, IT WAS DETERMINED THAT THE SWELLING ENDED UP BEING SECONDARY TO HEMATOMA RATHER THAN EXTRAVASATION. ALSO, THE INFUSION NURSE, STATED THEY HAVE HAD DIFFICULTY REFILLING THE PATIENT'S PUMP DUE TO WEIGHT GAIN AND ADIPOSE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532761 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30377678 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| O| R