BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23381654 · Received October 24, 2025

    Report

    Report Number
    3015537318-2025-00098
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 25, 2025
    Report Date
    January 20, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 OCTOBER 2, 2025, INTERA ONCOLOGY SHIPPED A RETURN KIT TO OUR REPRESENTATIVE TO HAVE THE ACTUAL DEVICE RETURN FOR EXAMINATION. TO DATE, THE PUMP HAS NOT BEEN RETURNED. THEREFORE, ONCE WE RECEIVE THE PUMP AND IT'S EVALUATED, 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 DEVICE WAS EVALUATED IN HOUSE. THE COMPLAINT FOR THE PUMP BEING UNABLE TO BOLUS COULD NOT BE REPLICATED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP CATHETER DID NOT FLUSH DURING PUMP PREPARATION. THE PUMP EMPTIED 15 ML BACTERIOSTATIC WATER AND WAS FILLED WITH 30ML HIGH-DOSE HEPARINIZED SALINE. THE SPECIAL BOLUS NEEDLE (SBN) WAS ATTACHED TO 10ML SYRINGE OF LOW-DOSE HEP SALINE. THE SCRUB NURSE ATTEMPTED TO FLUSH AS PER PROTOCOL, AND THE CATHETER WOULD NOT FLUSH. OUR REPRESENTATIVE VISUALLY CONFIRMED THAT THE SCRUB NURSE WAS CONTACTING THE NEEDLE STOPPER. THEN THE SCRUB NURSE REMOVE THE SBN FROM PUMP SEPTUM AND CONFIRMED THAT THE SYSTEM WAS PATENT, SHE REATTEMPTED, AND CATHETER WOULD NOT FLUSH. A BACKUP SBN WAS USED, AND THE CATHETER DID NOT FLUSH. THE SURGEON CAME TO TROUBLESHOOT, AND HE WAS UNABLE TO FLUSH CATHETER AND DETERMINED THE BEST COURSE OF ACTION WAS TO OPEN AND PREPARE THE BACKUP PUMP. THE NEW PUMP PREPPED WITHOUT DIFFICULTY.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP CATHETER DID NOT FLUSH DURING PUMP PREPARATION. THE PUMP EMPTIED 15 ML BACTERIOSTATIC WATER AND WAS FILLED WITH 30ML HIGH-DOSE HEPARINIZED SALINE. THE SPECIAL BOLUS NEEDLE (SBN) WAS ATTACHED TO 10ML SYRINGE OF LOW-DOSE HEP SALINE. THE SCRUB NURSE ATTEMPTED TO FLUSH AS PER PROTOCOL, AND THE CATHETER WOULD NOT FLUSH. OUR REPRESENTATIVE VISUALLY CONFIRMED THAT THE SCRUB NURSE WAS CONTACTING THE NEEDLE STOPPER. THEN THE SCRUB NURSE REMOVE THE SBN FROM PUMP SEPTUM AND CONFIRMED THAT THE SYSTEM WAS PATENT, SHE REATTEMPTED, AND CATHETER WOULD NOT FLUSH. A BACKUP SBN WAS USED, AND THE CATHETER DID NOT FLUSH. THE SURGEON CAME TO TROUBLESHOOT, AND HE WAS UNABLE TO FLUSH CATHETER AND DETERMINED THE BEST COURSE OF ACTION WAS TO OPEN AND PREPARE THE BACKUP PUMP. THE NEW PUMP PREPPED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531817 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30146270 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown