BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23787803 · Received December 12, 2025

    Report

    Report Number
    3015537318-2025-00118
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 13, 2025
    Report Date
    February 17, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE PUMP WAS TESTED IN HOUSE AND THE COMPLAINT OF THE PUMP BEING UNABLE TO BOLUS COULD NOT BE REPLICATED.

    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. ON (B)(6) 2025, INTERA ONCOLOGY SHIPPED OUT RETURN KIT TO RETRIEVE THE DEVICE FOR EVALUATION. TO DATE, THE PUMP HAS NOT BEEN RECEIVED. THEREFORE, ONCE THE PUMP I RECEIVED AND THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN WHEN THE SCRUB TECH ATTEMPTED TO FLUSH THE BOLUS PATHWAY WITH LOW DOSE HEPARINIZED SALINE USING A PRIMED SPECIAL BOLUS NEEDLE (SBN), SHE WAS UNABLE TO FLUSH THE CATHETER. AFTER FOUR ATTEMPTS AT PULLING OUT THE NEEDLE AND REINSERTING IT PERPENDICULAR TO THE PUMP, THEY TOOK OUT A SBN FROM THE OR PREP KIT OF BACK UP PUMP SERIAL NUMBER (B)(6) AND ATTEMPTED TO A FIFTH TIME TO RULE OUT ANY DEFECTS IN PUMP SERIAL NUMBER (B)(6) SECOND SBNS. THE RESULT WAS THE SAME, SO THE CLINIC DECIDED TO OPEN AND PREP BACK UP PUMP SERIAL NUMBER (B)(6). THERE WERE NO ISSUES DURING THE PREP FOR THE BACKUP PUMP (B)(6) AND IT WAS IMPLANTED SUCCESSFULLY. IN ADDITION, IT WAS REPORTED THAT THE SCRUB TECH TOUCHED THE CATHETER OF PUMP SERIAL NUMBER (B)(6) AND NOTICED THAT A PART OF THE CATHETER FELT A LOT HARD COMPARED TO THE REST.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN WHEN THE SCRUB TECH ATTEMPTED TO FLUSH THE BOLUS PATHWAY WITH LOW DOSE HEPARINIZED SALINE USING A PRIMED SPECIAL BOLUS NEEDLE (SBN), SHE WAS UNABLE TO FLUSH THE CATHETER. AFTER FOUR ATTEMPTS AT PULLING OUT THE NEEDLE AND REINSERTING IT PERPENDICULAR TO THE PUMP, THEY TOOK OUT A SBN FROM THE OR PREP KIT OF BACK UP PUMP SERIAL NUMBER (B)(6) AND ATTEMPTED TO A FIFTH TIME TO RULE OUT ANY DEFECTS IN PUMP SERIAL NUMBER (B)(6) SECOND SBNS. THE RESULT WAS THE SAME, SO THE CLINIC DECIDED TO OPEN AND PREP BACK UP PUMP SERIAL NUMBER (B)(6). THERE WERE NO ISSUES DURING THE PREP FOR THE BACKUP PUMP (B)(6) AND IT WAS IMPLANTED SUCCESSFULLY. IN ADDITION, IT WAS REPORTED THAT THE SCRUB TECH TOUCHED THE CATHETER OF PUMP SERIAL NUMBER (B)(6) AND NOTICED THAT A PART OF THE CATHETER FELT A LOT HARD COMPARED TO THE REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703359 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30963569 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown