BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 23480046 · Received November 5, 2025

    Report

    Report Number
    3015537318-2025-00101
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 4, 2025
    Report Date
    November 4, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. WHILE THE EXACT CAUSE FOR THE BILIARY STRICTURE IS UNKNOWN, THE ROOT CAUSE IS LIKELY TO BE RELATED TO PATIENT CONDITION.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED AN EMAIL FROM A PHARMACIST ON OCTOBER 4, 2025, THAT THE HOSPITAL'S INPATIENT SURGICAL ONCOLOGY TEAM REACHED OUT TO THE PHARMACIST REGARDING A PUMP REFILL. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR BILIARY STRICTURE CAUSING TRANSAMINITIS AND MISSED PUMP REFILL ON (B)(6) 2025. THE INPATIENT TEAM WAS GOING TO REFILL WITH HEP/SALINE + DEX. INTERA ONCOLOGY ASKED THE PHARMACIST IF THE BILIARY STRICTURE WAS THOUGHT TO BE RELATED TO FLOXURIDINE OR DISEASE PROGRESSION AND SHE IS ASKING THE TEAM. THE PHARMACIST REACHED OUT TO THE INPATIENT TEAM TWICE AND HAS NOT HEARD BACK FROM THEM TO FIND OUT IF THE BILIARY STRICTURE WAS RELATED TO FLOXURIDINE OR DISEASE PROGRESSION. THE LATEST INFORMATION THAT WE ARE AWARE OF IS THAT THE PATIENT HAS NOT RETURNED TO ACTIVE TREATMENT. THE PATIENT WENT FROM HEP/SALINE + DEX TO GLYCERIN AND LAST NOTE MENTIONED MAYBE GOING BACK TO HEP/SALINE + DEX BUT HAS NOT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681909 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 29697757 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| O FLOXURIDINE FOR INJECTION, USP 500 MG/VIAL.