BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23036391 · Received September 12, 2025

    Report

    Report Number
    3015537318-2025-00089
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 18, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    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. INTERA ONCOLOGY QUALITY DEPARTMENT INTERVIEWED THE REPRESENTATIVE OF INTERA ONCOLOGY WHO ASSISTED THE PHYSICIAN. SHE MENTIONED THAT THE ROOT CAUSE OF THIS COMPLAINT WAS USE ERROR AS ONE OF THE PHYSICIANS DID NOT PLACE THE NEEDLE CORRECTLY INTO THE PUMP.

    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. INTERA ONCOLOGY QUALITY DEPARTMENT INTERVIEWED THE REPRESENTATIVE OF INTERA ONCOLOGY WHO ASSISTED THE PHYSICIAN. SHE MENTIONED THAT THE ROOT CAUSE OF THIS COMPLAINT WAS USE ERROR AS ONE OF THE PHYSICIANS DID NOT PLACE THE NEEDLE CORRECTLY INTO THE PUMP.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED CALL FROM PHYSICIAN ASSISTANT THAT REPORTED THE LIVER DID NOT UPTAKE THE ISOTOPE DURING THE HAPS SCAN. IT WAS CONFIRMED THAT THE NEEDLE WAS FULLY DEPRESSED AND ONLY A SMALL AMOUNT WAS IN THE RIGHT LOBE. A REPRESENTATIVE FROM INTERA ONCOLOGY SPOKE WITH THE PHYSICIAN; HE RELATED AGAIN THE NEEDLE WAS FULLY DEPRESSED AND SCANNED WITH FLUOROSCOPY. IT HAS BEEN 16 DAYS SINCE THE PATIENT WAS IMPLANTED SO OUR REPRESENTATIVE DID ASK THE INFUSION TEAM TO GO AHEAD AND REFILL THE PUMP. THE FLOW RATE REPORTED FROM THE NURSE WAS 1.3 ML/DAY. THE PATIENT RETURNED FOR A FOLLOW UP SCAN ON (B)(6) 2025. THE PHYSICIAN REPORTED AGAIN THAT THE NEEDLE WAS FULLY DEPRESSED, AND THE ISOTOPE WAS SITTING IN THE CHAMBER. THE PHYSICIAN CONFIRMED THEY WERE USING THE SPECIAL BOLUS NEEDLE. ON (B)(6) 2025, THE FLOW RATE WAS MEASURED AT 1.3 ML/DAY. THE SCAN SHOWED THE CATHETER WAS NOT KINK. ANOTHER PHYSICIAN PERFORMED A REPEAT HAPS SCAN ON (B)(6) 2025, WITH OUR REPRESENTATIVE ON SITE. THE SCAN WAS REPEATED, AND NEEDLE VISIBILITY WAS FULLY DEPRESSED. LIVER SCAN SHOWED NO MISPERFUSION AND BOTH LOBES WERE PERFECTLY CLEAR WITH ISOTOPE. THE PHYSICIAN APPROVED FOR THE PATIENT TO BEGIN FLOXURIDINE TREATMENT ON (B)(6) 2025.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED CALL FROM PHYSICIAN ASSISTANT THAT REPORTED THE LIVER DID NOT UPTAKE THE ISOTOPE DURING THE HAPS SCAN. IT WAS CONFIRMED THAT THE NEEDLE WAS FULLY DEPRESSED AND ONLY A SMALL AMOUNT WAS IN THE RIGHT LOBE. A REPRESENTATIVE FROM INTERA ONCOLOGY SPOKE WITH THE PHYSICIAN; HE RELATED AGAIN THE NEEDLE WAS FULLY DEPRESSED AND SCANNED WITH FLUOROSCOPY. IT HAS BEEN 16 DAYS SINCE THE PATIENT WAS IMPLANTED SO OUR REPRESENTATIVE DID ASK THE INFUSION TEAM TO GO AHEAD AND REFILL THE PUMP. THE FLOW RATE REPORTED FROM THE NURSE WAS 1.3 ML/DAY. THE PATIENT RETURNED FOR A FOLLOW UP SCAN ON (B)(6) 2025. THE PHYSICIAN REPORTED AGAIN THAT THE NEEDLE WAS FULLY DEPRESSED, AND THE ISOTOPE WAS SITTING IN THE CHAMBER. THE PHYSICIAN CONFIRMED THEY WERE USING THE SPECIAL BOLUS NEEDLE. ON (B)(6) 2025, THE FLOW RATE WAS MEASURED AT 1.3 ML/DAY. THE SCAN SHOWED THE CATHETER WAS NOT KINK. ANOTHER PHYSICIAN PERFORMED A REPEAT HAPS SCAN ON (B)(6) 2025, WITH OUR REPRESENTATIVE ON SITE. THE SCAN WAS REPEATED, AND NEEDLE VISIBILITY WAS FULLY DEPRESSED. LIVER SCAN SHOWED NO MISPERFUSION AND BOTH LOBES WERE PERFECTLY CLEAR WITH ISOTOPE. THE PHYSICIAN APPROVED FOR THE PATIENT TO BEGIN FLOXURIDINE TREATMENT ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192445 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30377678 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male