BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 21809252 · Received April 9, 2025

    Report

    Report Number
    3015537318-2025-00026
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 9, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD, RTR-0883-20001 LN 29726471, WAS REVIEWED. THE PUMP WAS MANUFACTURED ON MAY 30, 2024. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. ACCORDING TO THE PHYSICIAN, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE HAPS SCAN RESULT WAS NORMAL. THE PHYSICIAN ALSO DISCOVERED THAT HIS PARTNER ACCIDENTALLY ASPIRATED THE PUMP AFTER INJECTING THE METHYLENE BLUE IN THE OR, SO HE HAD CONCERN FOR A CLOT. GIVEN THIS, THE PHYSICIAN DECIDED TO PROCEED WITH TISSUE PLASMINOGEN ACTIVATOR (TPA) ON (B)(6) 2025. THE TPA WAS SUCCESSFUL, AND THE PUMP IS FLOWING APPROPRIATELY. IN ADDITION, THROMBOSIS IS A KNOWN ADVERSE EVENT ON THE LABELING OF THE INTERA 3000 PUMP.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT OF A PUMP NOT FLOWING. THE PUMP WAS IMPLANTED ON (B)(6) 2025. THE FIRST REFILL WAS ON (B)(6) 2025, AND THE RESIDUAL VOLUME WAS 28 CC OF HEP SALINE WITH DEXAMETHASONE. THE PATIENT WENT HOME AND PUT HEAT ON IT AND RETURN TO CLINIC ON (B)(6) 2025, AND THE RESIDUAL VOLUME WAS 28 CC OF HEP SALINE WITH DEXAMETHASONE. THE CLINIC IS TAKING PATIENT BACK FOR A SECOND HAPS SCAN TO LOOK AT PATENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664367 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 29304161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male