BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 19877975 · Received July 31, 2024

    Report

    Report Number
    3015537318-2024-00065
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 5, 2024
    Report Date
    July 31, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THERE WERE NO NONCONFORMANCES RELATED TO THIS SERIAL NUMBER. THE DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS PRIOR TO RELEASE FROM MANUFACTURING. THE HEALTHCARE PROVIDER REPORTED THAT THE DEVICE IS FUNCTIONING PROPERLY AND IT REMAINS IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A HEALTHCARE PROVIDER REPORTED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP THAT WAS IMPLANTED ON (B)(6) 2024 DID NOT RETURN. A RESIDUAL DURING THE FIRST REFILL OF THE DEVICE ON (B)(6) 2024, INDICATING FAST FLOW. DURING A FOLLOW UP ON (B)(6) 2024, THE HEATLHCARE PROVIDER REPORTED A FLOW RATE OF 1.3ML/DAY, WHICH IS WITHIN THE LABEL SPECIFICATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241200 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 29002623

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention