BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 22985472 · Received September 5, 2025

    Report

    Report Number
    3015537318-2025-00081
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    November 7, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. INTERA ONCOLOGY SENT OUT COMMUNICATIONS TO THE CLINIC MULTIPLE TIMES. AS OF TODAY, THE CLINIC HAS NOT RESPONDED TO OUR COMMUNICATIONS. THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT REMAINS 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. THE DEVICE REMAINS IMPLANTED AND IN USE. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE. AS PREVIOUSLY MENTIONED, THE PATIENT RESIDES IN A HIGH-ALTITUDE ZONE AND IS CONTINUING WITH TREATMENTS. THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP INSTRUCTION FOR USE INDICATES THE PUMP FLOW RATE CAN VARY FOR A PATIENT THAT IS LIVING AT AN ELEVATION ABOVE SEA LEVEL.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A CALL FROM A PHARMACIST SPECIALIST REGARDING A PATIENT'S PUMP RESIDUAL VOLUME DURING REFILL ON (B)(6) 2025. THE PATIENT DOES LIVE AT A HIGHER ALTITUDE, BUT HER FLOW RATE IS TYPICALLY 1.2-1.3 ML/DAY. THE PATIENT'S RESIDUAL VOLUME WAS 7 ML/DAY. THE PHARMACIST SPECIALIST WAS CONCERNED ABOUT THE PATIENT PUMP'S FLOW RATE. ON (B)(6) 2025, THE PATIENT WAS REFILLED WITH 30 ML OF HEPARIN, AND THE CLINIC WILL BRING THE PATIENT BACK IN AT THE END OF THE WEEK DUE TO CONCERNS OF THE PUMP FAST FLOWING. IF THE FLOW RATE HAS GONE BACK TO BASELINE, THEY WILL REFILL WITH FLOXURIDINE.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A CALL FROM A PHARMACIST SPECIALIST REGARDING A PATIENT'S PUMP RESIDUAL VOLUME DURING REFILL ON (B)(6) 2025. THE PATIENT DOES LIVE AT A HIGHER ALTITUDE, BUT HER FLOW RATE IS TYPICALLY 1.2-1.3 ML/DAY. THE PATIENT'S RESIDUAL VOLUME WAS 7 ML/DAY. THE PHARMACIST SPECIALIST WAS CONCERNED ABOUT THE PATIENT PUMP'S FLOW RATE. ON (B)(6) 2025, THE PATIENT WAS REFILLED WITH 30 ML OF HEPARIN, AND THE CLINIC WILL BRING THE PATIENT BACK IN AT THE END OF THE WEEK DUE TO CONCERNS OF THE PUMP FAST FLOWING. IF THE FLOW RATE HAS GONE BACK TO BASELINE, THEY WILL REFILL WITH FLOXURIDINE. ON (B)(6) 2025, THE PHARMACIST RESPONDED TO OUR EMAIL. SHE PROVIDED INTERA ONCOLOGY WITH THE LAST FOUR REFILL RESULTS PRIOR TO (B)(6) 2025: ON (B)(6) 2025: 6.5 ML EXTRACTED, (B)(6) 2025: 8 ML EXTRACTED, (B)(6) 2025: 7 ML EXTRACTED, (B)(6) 2025: 7 ML EXTRACTED. THE PATIENT DID NOT EXPERIENCE AN ADVERSE REACTION. THE PUMP FLOW RATE FROM (B)(6) 2025, WAS 8 ML EXTRACTED: FLOW RATE = 1.57 ML/DAY. THE PATIENT HAS RESUME FLOXURIDINE TREATMENT, WITH AN ADJUSTED, PATIENT SPECIFIC FLOW RATE (1.6 ML/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305018 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 28538291 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female