BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 24229128 · Received February 2, 2026

    Report

    Report Number
    3015537318-2026-00010
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 15, 2026
    Report Date
    January 30, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. THE EXACT CAUSE OF THE SLOW FLOW IS UNKNOWN AS THE PUMP REMAINS IMPLANTED TO THE PATIENT. HOWEVER, IT IS LIKELY THAT THE CAUSE OF THE RESISTANCE DURING BOLUS ATTEMPT COULD BE DUE TO THE NEEDLE PLACEMENT NOT BEING IN THE CORRECT POSITION OR EARLY INTRALUMINAL OBSTRUCTION (FIBRIN SHEATH FORMATION OR RESIDUAL FOREIGN MATERIAL (GLYCERIN), COULD HAVE BEEN IMPACTED DURING THE REPEATED BOLUS ATTEMPTS.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT FROM A NURSE THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS SLOW FLOWING. GLYCERIN FROM A COMPOUND PHARMACY WAS BEING ADMINISTERED TO THE PUMP. AT THE FIRST GLYCERIN REFILL ((B)(6) 2025), THE RESIDUAL VOLUME WAS 22 ML. DURING THE SECOND GLYCERIN REFILL ON (B)(6) 2026, THE RESIDUAL VOLUME WAS 26.5 ML. THE NURSE PROVIDED INTERA ONCOLOGY WITH ADDITIONAL CLINICAL CONTEXT AND A DETAILED FLOW-RATE TREND: ·THE PATIENT TRANSITIONED TO GLYCERIN UPON COMPLETION OF HAI-FUDR THERAPY ((B)(6) 2025). ·(B)(6) 2025: RESIDUAL 16 ML (14 DAYS), FLOW RATE 1.0 ML/DAY-LAST DOSE OF FUDR. ·(B)(6) 2025: RESIDUAL 16 ML (14 DAYS), FLOW RATE 1.0 ML/DAY-HEP SALINE (HS). ·(B)(6) 2025: RESIDUAL 16 ML (14 DAYS), FLOW RATE 1.0 ML/DAY-HS. ·(B)(6) 2025: NO DOCUMENTED RESIDUAL-HS. ·(B)(6) 2025: RESIDUAL 15.5 ML (14 DAYS), FLOW RATE 1.04 ML/DAY-HS. ·(B)(6) 2025: RESIDUAL 20 ML (11 DAYS), FLOW RATE 0.9 ML/DAY-HS. ·(B)(6) 2025: RESIDUAL 18.5 ML (10 DAYS), FLOW RATE 1.15 ML/DAY-HS. ·(B)(6) 2025: NO RESIDUAL OR FLOW RATE DOCUMENTED; PATIENT TRANSITIONED TO GLYCERIN (TYPE NOT SPECIFIED). ·(B)(6) 2025: GLYCERIN REFILL; RESIDUAL 22 ML AFTER 49 DAYS - CALCULATED FLOW RATE 0.16 ML/DAY. ·(B)(6) 2026: GLYCERIN REFILL; RESIDUAL 26.5 ML AFTER 56 DAYS - CALCULATED FLOW RATE 0.06 ML/DAY. THE INFUSION APP ATTEMPTED TO FLUSH THE BOLUS PATHWAY AND NOTED SIGNIFICANT RESISTANCE, DESCRIBED AS "LIKE HITTING A WALL", THE INFUSION APP REPOSITIONED THE NEEDLE AND FELT SOME IMPROVEMENT, THOUGH RESISTANCE PERSISTED. ON (B)(6) 2026, THE NURSE REPEATED BOLUS FLUSH WITH NEW NEEDLE AND ENSURED THAT IT WAS INJECTED PERPENDICULAR TO THE PUMP WITH CONTINUED RESISTANCE. THE NURSE DISCUSSED WITH THE SURGEON NEXT STEPS INCLUDING CT ANGIOGRAM AND PUMP ANGIOGRAM. ON (B)(6) 2026, THE CT ANGIOGRAM WAS DONE AND RESULT WAS NEGATIVE, IT DID NOT DESCRIBE ANY CONCERN FOR CATHETER MALPOSITION, THROMBOSIS, OR PSEUDOANEURYSM. THE CLINIC REATTEMPTED BOLUS FLUSH WITH 2-INCH NEEDLE AND THEY WERE ABLE TO FLUSH WITHOUT RESISTANCE. THE PLAN IS TO TRANSITION THE PATIENT BACK TO HEPARINIZED SALINE FROM GLYCERIN, GIVEN CONFIRMED BOLUS PATHWAY PATENCY ON FLUSH (NO PARTIAL RESISTANCE) AND NEGATIVE CT ANGIOGRAM RESULTS, PLAN FOR TRIAL OF HEAT AND RETURN 1 WEEK TO REASSESS FLOW RATE. THE PATIENT WITH SMALL LIVER RECURRENCE (UNCLEAR IF WILL RESUME HAI-FUDR VERSUS ABLATION), PLANS TO KEEP CATHETER PATENCY FOR NOW WITH HEP SALINE REFILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290614 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 27799144 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male