BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 25116183 · Received May 7, 2026

    Report

    Report Number
    3015537318-2026-00047
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 6, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2026, A RETURN KIT WAS SHIPPED TO THE HOSPITAL TO RETRIEVE THE PUMP. AS OF TODAY, WE ARE WAITING FOR THE ARRIVAL OF THE DEVICE. ONCE THE DEVICE IS RECEIVE AND INVESTIGATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FLUSHED DURING THE PUMP PREP, BUT IT THEN FAILED TO FLUSH ONCE IMPLANTED. THREE SPECIAL BOLUS NEEDLES WERE USED, BUT IT WAS UNABLE TO FLUSH THE CATHETER PATHWAY PROPERLY. A BACKUP PUMP WAS OPENED AND PREPPED WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599328 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 32661733 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown