BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23043344 · Received September 12, 2025

    Report

    Report Number
    3015537318-2025-00086
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 18, 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
    TN, 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 ABLE TO BOLUS AND FLOW NORMALLY DURING TESTING; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS INCONCLUSIVE.

    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 SEPTEMBER 5, 2025, INTERA ONCOLOGY SHIPPED A RETURN KIT TO THE PHYSICIAN OFFICE TO RETRIEVE THE ACTUAL DEVICE 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.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN WHILE THE PUMP WAS BEING PREPPED, THE PUMP WAS EMPTIED, FILLED, BUT THE CATHETER COULD NOT BE FLUSHED. THE PHYSICIAN TRIED TO DO THIS WITH THE SPECIAL BOLUS NEEDLE (SBN) BUT WAS NOT SUCCESSFUL. THE PHYSICIAN SPOKE TO A REPRESENTATIVE FROM INTERA ONCOLOGY, OUR REPRESENTATIVE ASKED THE PHYSICIAN TO CONFIRM THE KNOT WAS CUT OFF THE TIP OF THE CATHETER, THE CLAMP WAS UNCLAMPED, AND THE SBN WAS FULLY INSERTED INTO THE PUMP. THE PHYSICIAN ASSURED US ALL OF THIS HAD BEEN DONE. IN ADDITION, THE PHYSICIAN MENTIONED THIS WAS HIS THIRD SBN HE'D TRY TO FLUSH THE PUMP WITH AND THAT HE'D ALREADY CONFIRMED FLOW OF THE SBN TUBING AND NEEDLE WHEN THE NEEDLE WAS NOT IN THE PUMP SEPTUM. THE DECISION WAS MADE TO OPEN A NEW PUMP.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A PHYSICIAN WHILE THE PUMP WAS BEING PREPPED, THE PUMP WAS EMPTIED, FILLED, BUT THE CATHETER COULD NOT BE FLUSHED. THE PHYSICIAN TRIED TO DO THIS WITH THE SPECIAL BOLUS NEEDLE (SBN) BUT WAS NOT SUCCESSFUL. THE PHYSICIAN SPOKE TO A REPRESENTATIVE FROM INTERA ONCOLOGY, OUR REPRESENTATIVE ASKED THE PHYSICIAN TO CONFIRM THE KNOT WAS CUT OFF THE TIP OF THE CATHETER, THE CLAMP WAS UNCLAMPED, AND THE SBN WAS FULLY INSERTED INTO THE PUMP. THE PHYSICIAN ASSURED US ALL OF THIS HAD BEEN DONE. IN ADDITION, THE PHYSICIAN MENTIONED THIS WAS HIS THIRD SBN HE'D TRY TO FLUSH THE PUMP WITH AND THAT HE'D ALREADY CONFIRMED FLOW OF THE SBN TUBING AND NEEDLE WHEN THE NEEDLE WAS NOT IN THE PUMP SEPTUM. THE DECISION WAS MADE TO OPEN A NEW PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960414 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 29935129 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown