BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 22298767 · Received June 20, 2025

    Report

    Report Number
    3015537318-2025-00059
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 22, 2025
    Report Date
    June 20, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD, (B)(4) LN 29977941, WAS REVIEWED. THE PUMP WAS MANUFACTURED ON SEPTEMBER 24, 2024. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. BASED ON THE INFORMATION WE OBTAINED AND ANALYZED, THE CAUSE OF THIS INCIDENT IS USE ERROR AS THE CLINIC DID NOT INJECT THE SPECIAL BOLUS NEEDLE PROPERLY INTO THE BOLUS PATHWAY AS THE TECHNETIUM-99M MACROAGGREGATED ALBUMIN (TC99MA) WAS SITTING ON TOP OF THE PUMP UNDER THE SKIN, INSTEAD OF GOING THROUGH THE PUMP. MOREOVER, THE PHYSICIAN STATED TO INTERA ONCOLOGY THAT HE BELIEVED THE NUCLEAR MEDICINE TECHNICIAN HAD A TECHNICAL ISSUE PERFORMING THE STUDY. AS PREVIOUSLY MENTIONED, THE PHYSICIAN CONFIRMED THAT A SECOND HAPS SCAN WAS PERFORMED AND SHOWED GOOD PERFUSION OF THE ENTIRE LIVER WITH NO EXTRAHEPATIC PERFUSION. IN ADDITION, INTERA ONCOLOGY REACHED OUT TO THE PHYSICIAN MULTIPLE TIMES TO GATHER THE REQUIRED PATIENT INFORMATION (PART A) AND IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECT. AS OF TODAY, NO RESPONSES HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY WAS INFORMED BY A PHYSICIAN THAT A PUMP PLACED ON B)(6) 2025, AND HAD A HAPS SCAN ON (B)(6) 2025, THAT DID NOT SHOW APPROPRIATE PERFUSION OF THE LIVER. THE PHYSICIAN INFORMED INTERA ONCOLOGY ON (B)(6) 2025, IN THE LATE EVENING, BECAUSE NUCLEAR MEDICINE (NUC MED) REPORTED AT 5 PM THERE WAS "MINIMAL RADIOTRACER UPTAKE TRAVEL FROM THE PUMP TO THE LIVER CONCERNING A KINK IN THE LINE." THE PHYSICIAN REPORTED TO INTERA HE WAS TAKING PATIENT BACK TO OR. THE PHYSICIAN TOOK THE PATIENT BACK INTO THE OR ON THE NIGHT OF (B)(6) 2025, TO CONFIRM THAT THE CATHETER WAS NOT KINKED. HE PERFORMED A METHYLENE BLUE DYE TEST AND CONFIRMED APPROPRIATE PERFUSION. ON (B)(6) 2025, THE PHYSICIAN REPORTED BACK TO INTERA ONCOLOGY, EVERYTHING WENT GREAT, NO PROBLEM INJECTING AND NO MISPERFUSION. THE PHYSICIAN SUGGESTED THE NUC MED HAD A TECHNICAL ISSUE PERFORMING THE STUDY. ON (B)(6) 2025, AT 9:30 AM, HAPS SCAN IMAGES WERE SENT TO INTERA CLINICAL. IT APPEARS THAT THE TC99MA DID NOT INJECT IMPROPERLY INTO THE BOLUS PATHWAY. IT APPEARED THAT THE TC99MA IS SITTING ON TOP OF THE PUMP UNDER THE SKIN. ON (B)(6), 2025, THE PHYSICIAN REPORTED THEY WERE REPEATING THE HAPS SCAN. ON (B)(6) 2025, A REPRESENTATIVE FROM INTERA ONCOLOGY RECEIVED CONFIRMATION OVER PHONE THAT THE NUC MED ONLY USED A SPECIAL BOLUS NEEDLE. ON (B)(6) 2025, A REPRESENTATIVE OF INTERA ONCOLOGY FOLLOWED UP WITH THE PHYSICIAN. THE PHYSICIAN CONFIRMED THAT A SECOND HAPS SCAN WAS PERFORMED AND SHOWED GOOD PERFUSION OF THE ENTIRE LIVER WITH NO EXTRAHEPATIC PERFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806093 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30146270 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown