BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23787812 · Received December 12, 2025

    Report

    Report Number
    3015537318-2025-00116
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 26, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. ON (B)(6) 2025, INTERA ONCOLOGY RECEIVED THE ACTUAL PUMP AND SPECIAL BOLUS NEEDLE. TO DATE, THE INVESTIGATION REMAINS ONGOING. THEREFORE, ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 COMPLAINT ALLEGATION OF UNABLE TO BOLUS WAS ABLE TO BE CONFIRMED. THE CAUSE IS TRACED TO MANUFACTURING.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN THAT WHEN PREPPING THE PUMP, THE BOLUS PATHWAY WOULD NOT FLUSH. THE PHYSICIAN REMOVED AND RECENTERED THE NEEDLE MULTIPLE TIMES AND TRIED A SECOND SPECIAL BOLUS NEEDLE (SBN) AND STILL WOULD NOT FLUSH. THE PUMP WAS NOT PLACED INTO THE PATIENT.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED BY A PHYSICIAN THAT WHEN PREPPING THE PUMP, THE BOLUS PATHWAY WOULD NOT FLUSH. THE PHYSICIAN REMOVED AND RECENTERED THE NEEDLE MULTIPLE TIMES AND TRIED A SECOND SPECIAL BOLUS NEEDLE (SBN) AND STILL WOULD NOT FLUSH. THE PUMP WAS NOT PLACED INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161486 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30963569 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown