BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20212166 · Received September 13, 2024

    Report

    Report Number
    3015537318-2024-00079
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 13, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AT THE TIME OF THIS REPORT AND IS NOT AVAILABLE FOR EVALUATION. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS SERIAL NUMBER. THERE WAS 1 DEVIATION RELATED TO THE MANUFACTURE OF THIS LOT. SILICONE ADHESIVE USED IN THE MANUFACTURE OF THIS LOT CAME IN CONTAINERS SMALLER THAN THE SPECIFIED SIZE. THE MATERIAL IS THE SAME, ONLY PACKAGED IN A SMALLER CONTAINER. THE DEVIATION HAD NO IMPACT ON THE MANUFACTURE OF THIS LOT. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. BLANK FIELDS IN THE MDR REPORT REPRESENT UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A HEALTHCARE PROVIDER REPORTED TO INTERA ONCOLOGY THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS SHOWING HIGH RESIDUALS (18ML) AND LOW FLOW RATE (0.8ML) DURING REFILL. AN INTERA CLINICAL ACCOUNT SPECIALIST FOLLOWED UP WITH INSTRUCTIONS ON MANAGING SLOW FLOWING PUMPS. THE HEALTHCARE PROVIDER ALLEGES THAT THE PUMP HAS BEEN GETTING PROGRESSIVELY SLOWER SINCE APRIL 2024. A NUCLEAR MEDICINE STUDY WAS PERFORMED IN APRIL 2024 AND THE RESULT WAS CLEAR ACCORDING TO THE HEALTHCARE PROVIDER. THE PUMP REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208915 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 29024 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention