BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20202478 · Received September 12, 2024

    Report

    Report Number
    3015537318-2024-00078
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 14, 2024
    Report Date
    October 8, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERA ONCOLOGY FOLLOW-UP WITH THE CLINIC MULTIPLE TIMES. THE CLINIC MENTIONED THAT THE PUMP IS OPERATING, EVEN THOUGH, "NOT RUNNING EXACTLY TO WHAT IT IS PROGRAMMED FOR BUT NOTHING MAJOR. MORE JUST THAT EACH PATIENT SEEMS TO RUN BETWEEN 1.1-1.2ML/DAY CONSISTENTLY". NO REPORT OF PATIENT'S ADVERSE EFFECT. DEVICE REMAINS IMPLANTED AND IN USE WITH THE PATIENT. THE CAUSE OF THIS EVENT IS UNCONFIRMED. THE DEVICE HISTORY RECORD, RTR-0883-20001 L/N 29225, WAS REVIEWED. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING.

    Additional Manufacturer Narrative · 0

    TO DATE, THE INTERA 3000 HAI PUMP REMAINS IMPLANTED ON THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. INTERA ONCOLOGY IS PRESENTLY INVESTIGATING THE ROOT CAUSE OF THE REPORTED INCIDENT AND IS EXAMINING THE FLOW RATE DATA PROVIDED BY THE CLINIC. IN ADDITION, WE'RE IN COMMUNICATION WITH THE CLINIC TO SEEK ADDITIONAL INFORMATION FOR CLARIFICATION PURPOSES. THE CAUSES OF THIS INCIDENT ARE INCONCLUSIVE. THEREFORE, ONCE WE OBTAIN UPDATED INFORMATION, WE'LL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT THE INTERA 3000 HAI PUMP CALCULATED FLOW RATE WAS 0.93ML/D. THE FLOW RATE FOR THIS INTERA 3000 HAI PUMP IS 1.3ML/D AS MANUFACTURED. THE CLINIC PROVIDED INTERA ONCOLOGY THE PUMPS FLOW RATE DATE FROM THE LAST THREE MONTHS: (B)(6) 2024 - 14ML RETURN, 1.14ML/DAY FLOW RATE. (B)(6) 2024 - 14ML RETURN, 1.14ML/DAY FLOW RATE. (B)(6) 2024 - 15ML RETURN, 1.1ML/DAY FLOW RATE. (B)(6) 2024 - 15.5ML RETURN, 1.03ML/DAY FLOW RATE. (B)(6) 2024 - 16ML RETURN, 1.0ML/DAY FLOW RATE. (B)(6) 2024 - 16ML RETURN, 1.0ML/DAY FLOW RATE. (B)(6) 2024 - 17ML RETURN, 0.93ML/DAY FLOW RATE.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT THE INTERA 3000 HAI PUMP CALCULATED FLOW RATE WAS 0.93ML/D. THE FLOW RATE FOR THIS INTERA 3000 HAI PUMP IS 1.3ML/D AS MANUFACTURED. THE CLINIC PROVIDED INTERA ONCOLOGY THE PUMPS FLOW RATE DATE FROM THE LAST THREE MONTHS: ON (B)(6) 2024 - 14ML RETURN, 1.14ML/DAY FLOW RATE. ON (B)(6) 2024- 14ML RETURN, 1.14ML/DAY FLOW RATE. ON (B)(6) 2024- 15ML RETURN, 1.1ML/DAY FLOW RATE. ON (B)(6) 2024- 15.5ML RETURN, 1.03ML/DAY FLOW RATE. ON (B)(6) 2024- 15ML RETURN, 1.1ML/DAY FLOW RATE. ON (B)(6) 2024- 16ML RETURN, 1.0ML/DAY FLOW RATE. ON (B)(6) 2024- 16ML RETURN, 1.0ML/DAY FLOW RATE. ON (B)(6) 2024- 17ML RETURN, 0.93ML/DAY FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592026 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 29283 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention