BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23832650 · Received December 17, 2025

    Report

    Report Number
    3015537318-2025-00119
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 15, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    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 DEVICE REMAINS IMPLANTED AND IN USE. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS INCONCLUSIVE.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS SLOW FLOWING. OUR REPRESENTATIVE DISCUSSED WITH THE CLINIC FLUSHING THE BOLUS PATHWAY TO ASSESS ANY COMPLETE OR PARTIAL RESISTANCE, AS THIS MAY HELP TO DETERMINE WHETHER ADDITIONAL IMAGING IS NEEDED. IF THERE WAS NO RESISTANCE VIA THE BOLUS PATHWAY, TO CONSIDER A SHORT-TERM HEAT TRIAL OVER THE PUMP WITH SHORT-INTERVAL FOLLOW-UP. THE CLINIC PROVIDED INTERA ONCOLOGY WITH THE FLOW RATE SINCE IMPLANT: ON (B)(6) 2025: IMPLANT (MANUFACTURE-LABELED FLOW RATE 1.3 ML/D), ON (B)(6) 2025: HAPS SCAN - NEGATIVE FOR EXTRAHEPATIC PERFUSION, ON (B)(6) 2025: C1D1 FUDR; FLOW RATE 1.3 ML/D, ON (B)(6) 2025: HS ONLY; FLOW RATE 1.25 ML/D (RESIDUAL ~ 14ML), ON (B)(6) 2025: C2D1 FUDR (SAME DOSE); FLOW RATE 1.14 ML/D (RESIDUAL ~ 14ML), ON (B)(6) 2025: HS ONLY; FLOW RATE 1.03 ML/D (RESIDUAL ~ 15.5 ML). ON (B)(6) 2025, THE PHYSICIAN FLUSHED THE BOLUS PATHWAY WITH NO RESISTANCE. THE PLAN WAS TO TRIAL HEAT WITH SHORT-INTERVAL (5-DAY) FOLLOW-UP TO REASSESS. ON (B)(6) 2025, THE PATIENT RETURNED FOR SHORT-INTERVAL FOLLOW-UP WITH FLOW RATE CALCULATED AT 1.14 ML/DAY. THE PUMP WAS REFILLED WITH HEP SALINE. THE CLINIC PLANNED FOR 1-WEEK FOLLOW-UP TO RECHECK (B)(6) 2025). ON (B)(6) 2025, THE FLOW RATE MEASURED AT 1.17 ML/DAY (~10% DEVIATION FROM THE MANUFACTURED FLOW RATE). THE TEAM RESUMED THERAPY, AND FLOXURIDINE WAS ADMINISTERED. THE FIRST SET OF RESTAGING IMAGING IS PLANNED IN APPROXIMATELY TWO WEEKS. THE TEAM WILL CONTINUE TO MONITOR FLOW RATE CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248138 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30555094 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male