BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 25050176 · Received April 30, 2026

    Report

    Report Number
    3015537318-2026-00040
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 27, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE LIKELY ROOT CAUSE OF THIS COMPLAINT IS USE ERROR AS THE PATIENT MISSED THEIR REFILL APPOINTMENT ON (B)(6) 2026. THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP INSTRUCTIONS FOR USE INDICATES THAT "THE PATIENT MUST RETURN ON ESTABLISHED REFILL TIMES TO PREVENT THE PUMP FROM RUNNING DRY AS THIS CAN LEAD TO FORMATION OF A BLOOD CLOT AT THE CATHETER TIP AND INTERFERE WITH PROPER THERAPY APPLICATION."

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS NOTIFIED BY A PHARMACIST THAT A PATIENT LOST TO FOLLOW-UP. THE PATIENT HAD LEFT THE HOSPITAL AGAINST MEDICAL ADVICE AND WAS SUBSEQUENTLY ADMITTED TO AN OUTSIDE HOSPITAL. THE PATIENT HAD PREVIOUSLY BEEN ON GLYCERIN. LAST PUMP REFILL WAS ON (B)(6) 2026, WITH HEPARINIZED SALINE; THE PATIENT SHOULD HAVE RETURNED ON (B)(6) 2026, BUT THERE WERE NO INTERVAL REFILLS, AND THE PATIENT RETURNED ON (B)(6) 2026. THERE WAS CONCERN FOR A DRY PUMP GIVEN THE ELAPSED TIME SINCE THE LAST REFILL. THE CLINIC INFORMED INTERA THAT THE BOLUS PATHWAY WAS FLUSHED WITHOUT RESISTANCE AND THAT THE PUMP WAS REFILLED WITH HEPARINIZED SALINE. THE PLAN WAS FOR THE PATIENT TO RETURN IN 2 WEEKS, ALTHOUGH THE TEAM IS CONSIDERING AN EARLIER VISIT; BUT GIVEN THE PATIENT'S DISTANCE FROM CLINIC THEY WILL DISCUSS THIS INTERNALLY. THE CLINIC INFORMED INTERA ONCOLOGY THAT ON (B)(6) 2026, THE PUMP IS WORKING AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326161 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30139907 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown