BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23116626 · Received September 22, 2025

    Report

    Report Number
    3015537318-2025-00091
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    July 12, 2023
    Report Date
    September 22, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    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 ATTEMPTED MULTIPLE TIMES TO COMMUNICATE WITH THE PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED. THEREFORE, IF WE RECEIVE UPDATED INFORMATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING AN INTERNAL DEVICE TRACKING AUDIT/REVIEW, WE DISCOVERED 2 INTERA 3000 HEPATIC ARTERY INFUSION PUMPS LISTED UNDER ONE PATIENT. THE RECORDS SHOW THAT PUMP SERIAL NUMBER (B)(6) WAS IMPLANTED ON (B)(6)2023, AND PUMP SERIAL NUMBER (B)(6) WAS IMPLANTED ON (B)(6)2023. OUR ASSUMPTION IS THAT PUMP SERIAL NUMBER (B)(6) WAS EXPLANTED ON (B)(6)2023. THE REASONS FOR EXPLANTATION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581202 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 28833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other