BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20195674 · Received September 11, 2024

    Report

    Report Number
    3015537318-2024-00076
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 11, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTERA 3000 HAI PUMP REMAINS IMPLANTED ON THE PATIENT. THE DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO NONCONFORMANCE'S PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. THE CAUSE OF THE ALLEGED FLOW RATE DISCREPANCY IS UNDETERMINED. HOWEVER, AS PREVIOUSLY MENTIONED IN SECTION B5, THE DOCTOR MENTIONED THAT AN UNDERFILL WAS LIKELY. THEREFORE, INDICATING A LIKELY USER ERROR. IN ADDITION, THE DOCTOR CONFIRMED THAT DEVICE FLOW RATE HAS BEEN AT THE NORMAL RATE SINCE (B)(6) 2024. TO DATE, NO ADDITIONAL PRODUCT COMPLAINT HAS BEEN RECEIVED FOR THIS INTERA 3000 HAI PUMP.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT THE INTERA 3000 HAI PUMP CALCULATED FLOW RATE WAS 2.6ML/D. THE FLOW RATE FOR THIS INTERA 3000 HAI PUMP IS 1.2ML/D AS MANUFACTURED. DURING FOLLOW UP, THE DOCTOR MENTIONED THAT DURING REFILL DATE OF (B)(6) 2024 THE PUMP OVERINFUSE. HOWEVER, THE DOCTOR LATER STATED THAT THE FLOW RATE ISSUE WAS RESOLVED AND WAS LIKELY AN UNDERFILL. IN ADDITION, THE DOCTOR MENTIONED THAT EFFECTIVE AUGUST 20, 2024, THE DEVICE FLOW RATE WAS BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558472 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28829798 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention