BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 22726490 · Received August 6, 2025

    Report

    Report Number
    3015537318-2025-00068
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 8, 2025
    Report Date
    September 23, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION. ONE NON-CONFORMANCE WAS OPENED FOR THERMOCOUPLES NOT READING WHICH CAUSED STERILIZATION TESTS TO NOT MEET SPECIFICATION. ANOTHER STERILIZATION CYCLE WAS COMPLETED AND DEVICE MET SPECIFICATION. THE CAUSE OF THE INCIDENT REMAINS INCONCLUSIVE DUE TO THE PUMP REMAINS IMPLANTED. INTERA ONCOLOGY REMAINS IN CONTACT WITH THE CLINIC TO OBTAIN THE LATEST RESULTS OF THE FLOW RATE CHECK AND REFILL. ONCE WE OBTAIN UPDATED INFORMATION, 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. ONE NON-CONFORMANCE WAS OPENED FOR THERMOCOUPLES NOT READING WHICH CAUSED STERILIZATION TESTS TO NOT MEET SPECIFICATION. ANOTHER STERILIZATION CYCLE WAS COMPLETED AND DEVICE MET SPECIFICATION. THE CAUSE OF THE INCIDENT REMAINS INCONCLUSIVE DUE TO THE PUMP REMAINS IMPLANTED. HOWEVER, INTERA ONCOLOGY RECEIVED UPDATED INFORMATION FROM THE CLINIC. ON (B)(6) 2025, THE FLOW RATE WAS 1.25 ML/DAY. THE PATIENT RECEIVED 30 ML OF FLOXURIDINE AND WAS SCHEDULED TO RETURN TO THE CLINIC ON (B)(6) 2025, FOR THE NEXT REFILL. ON (B)(6) 2025, THE PUMP FLOW RATE WAS REPORTED TO BE BACK TO THE NORMAL RATE AT 1.3 ML/DAY.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT REPORT IN WHICH AN INTERA 3000 HAI PUMP WAS FLOWING FAST. THE PUMP WAS FILLED ON (B)(6) 2025. DURING THE REFILL THE PUMP WAS EMPTY AND FILLED WITH 30 ML'S OF SOLUTION. THE PATIENT (PT) WAS BROUGHT BACK ON (B)(6) 2025, AND THE PUMP WAS EMPTY AGAIN. THE NURSE PRACTITIONER (NP) STATED SHE ATTEMPTED TO REFILL THE PUMP BUT WAS UNABLE TO INJECT, ALTHOUGH SHE WAS ABLE TO INJECT 6 ML OF INJECTABLE SALINE AND ALL 6 RETURNED TO THE SYRINGE, BUT STILL UNABLE TO INSTILL THE HEPARIN. INTERA ONCOLOGY RECEIVED A CALL LATER IN THE DAY FROM THE NP TO DISCUSS THAT SHE HAD TRIED TO INJECT ISOTOPE USING THE SPECIAL BOLUS NEEDLE (SBN). THE NP CONFIRMED TWICE THAT SBN WAS USED AND THERE WAS NO UPTAKE IN THE LIVER, THE ISOTOPE LOOKED AS THOUGH IT WAS EITHER IN THE PUMP OR AROUND THE PUMP IN THE PUMP POCKET, PER SPECT. THE PATIENT WAS SCHEDULED TO BE BROUGHT BACK TO THE CLINIC ON (B)(6) 2025, TO ATTEMPT ANOTHER REFILL AND TENTATIVE SCAN. ON (B)(6) 2025, INTERA ONCOLOGY RECEIVED A CALL FROM THE NP. AN ATTEMPT TO ACCESS THE PUMP WAS DONE BY THE PHYSICIAN AND WAS STILL UNABLE TO ACCESS. THE PUMP WAS EMPTY, AND NOTHING RETURNED TO SYRINGE BARREL. TROUBLESHOOTING STEPS WERE ATTEMPTED AND OUR CLINICAL ACCOUNT SPECIALIST REQUESTED THE PHYSICIAN TO ATTACH 10 ML SYRINGE OF INJECTABLE SALINE. THE PHYSICIAN WAS UNABLE TO INJECT EVEN WITH FORCED PRESSURE. THE PHYSICIAN CONFIRMED THE NEEDLE WAS PLACED CORRECTLY, AND NEEDLE WAS DEPRESSED AND IN CONTACT WITH THE NEEDLE STOPPER. THE NP LATER CALLED BACK STATING THAT ADJUSTING THE NEEDLE WITH FORCED PRESSURE THEY WERE ABLE TO RECEIVE A RESIDUAL OF 5 ML. THE REST OF THE PUMP REFILL WAS SUCCESSFUL. THE PATIENT WAS SCHEDULED FOR FOLLOW UP REFILL AND FLOW RATE CHECK IN ONE WEEK. THE PATIENT WENT FOR A REFILL ON (B)(6) 2025, AND THE REFILL WAS SUCCESSFUL, THE PUMP WAS FILLED WITH 30 ML OF FUDR. ON (B)(6) 2025, THE PATIENT WENT FOR A REFILL, AND THE RESIDUAL VOLUME WAS 24 ML, FLOW RATE .5 ML/DAY, MEANING THAT THE PUMP WAS NOW SLOW FLOWING. THE CLINIC INSTILLED 30 ML OF HIGH DOSE HEPARIN AND ADVISED THE PATIENT TO APPLY A HEATING PAD AS MUCH AS POSSIBLE FOR 48 HOURS. THE PATIENT IS SCHEDULED TO RETURN FOR FLOW RATE CHECK AND REFILL.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT REPORT IN WHICH AN INTERA 3000 HAI PUMP WAS FLOWING FAST. THE PUMP WAS FILLED ON JUNE 30, 2025. DURING THE REFILL THE PUMP WAS EMPTY AND FILLED WITH 30 ML'S OF SOLUTION. THE PATIENT (PT) WAS BROUGHT BACK ON (B)(6) 2025, AND THE PUMP WAS EMPTY AGAIN. THE NURSE PRACTITIONER (NP) STATED SHE ATTEMPTED TO REFILL THE PUMP BUT WAS UNABLE TO INJECT, ALTHOUGH SHE WAS ABLE TO INJECT 6 ML OF INJECTABLE SALINE AND ALL 6 RETURNED TO THE SYRINGE, BUT STILL UNABLE TO INSTILL THE HEPARIN. INTERA ONCOLOGY RECEIVED A CALL LATER IN THE DAY FROM THE NP TO DISCUSS THAT SHE HAD TRIED TO INJECT ISOTOPE USING THE SPECIAL BOLUS NEEDLE (SBN). THE NP CONFIRMED TWICE THAT SBN WAS USED AND THERE WAS NO UPTAKE IN THE LIVER, THE ISOTOPE LOOKED AS THOUGH IT WAS EITHER IN THE PUMP OR AROUND THE PUMP IN THE PUMP POCKET, PER SPECT. THE PATIENT WAS SCHEDULED TO BE BROUGHT BACK TO THE CLINIC ON (B)(6) 2025, TO ATTEMPT ANOTHER REFILL AND TENTATIVE SCAN. ON (B)(6) 2025, INTERA ONCOLOGY RECEIVED A CALL FROM THE NP. AN ATTEMPT TO ACCESS THE PUMP WAS DONE BY THE PHYSICIAN AND WAS STILL UNABLE TO ACCESS. THE PUMP WAS EMPTY, AND NOTHING RETURNED TO SYRINGE BARREL. TROUBLESHOOTING STEPS WERE ATTEMPTED AND OUR CLINICAL ACCOUNT SPECIALIST REQUESTED THE PHYSICIAN TO ATTACH 10 ML SYRINGE OF INJECTABLE SALINE. THE PHYSICIAN WAS UNABLE TO INJECT EVEN WITH FORCED PRESSURE. THE PHYSICIAN CONFIRMED THE NEEDLE WAS PLACED CORRECTLY, AND NEEDLE WAS DEPRESSED AND IN CONTACT WITH THE NEEDLE STOPPER. THE NP LATER CALLED BACK STATING THAT ADJUSTING THE NEEDLE WITH FORCED PRESSURE THEY WERE ABLE TO RECEIVE A RESIDUAL OF 5 ML. THE REST OF THE PUMP REFILL WAS SUCCESSFUL. THE PATIENT WAS SCHEDULED FOR FOLLOW UP REFILL AND FLOW RATE CHECK IN ONE WEEK. THE PATIENT WENT FOR A REFILL ON (B)(6) 2025, AND THE REFILL WAS SUCCESSFUL, THE PUMP WAS FILLED WITH 30 ML OF FUDR. ON (B)(6) 2025, THE PATIENT WENT FOR A REFILL, AND THE RESIDUAL VOLUME WAS 24 ML, FLOW RATE .5 ML/DAY, MEANING THAT THE PUMP WAS NOW SLOW FLOWING. THE CLINIC INSTILLED 30 ML OF HIGH DOSE HEPARIN AND ADVISED THE PATIENT TO APPLY A HEATING PAD AS MUCH AS POSSIBLE FOR 48 HOURS. THE PATIENT IS SCHEDULED TO RETURN FOR FLOW RATE CHECK AND REFILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556035 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30377677S

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male