BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 19012154 · Received April 1, 2024

    Report

    Report Number
    3015537318-2024-00032
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    March 14, 2024
    Report Date
    April 1, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFECTION IS A KNOWN ADVERSE EVENT ON THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP AS LISTED ON THE LABELING. THE STERILIZATION RECORDS FOR PUMP S/N (B)(6) WERE REVIEWED. THE STERILIZATION CYCLE, BIOBURDEN, AND ENDOTOXIN RESULTS MET ALL SPECIFICATIONS, SHOWING THAT IT IS UNLIKELY THAT THE DEVICE CAUSED THE INFECTION. IF FURTHER INFORMATION IS RECEVEIED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A HEALTHCARE PROVIDER THAT A PATIENT WHO WAS IMPLANTED WITH AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP HAD AN INFECTION. PUMP S/N (B)(6)WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024 IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTION. ON (B)(6) 2024, THE HEALTHCARE PROVIDER EXPLANTED PUMP S/N (B)(6) AND IMPLANTED PUMP S/N (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866982 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28155410S 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention