BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 24866666 · Received April 13, 2026

    Report

    Report Number
    3015537318-2026-00030
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 4, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    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. ON (B)(6) 2026, INTERA ONCOLOGY RECEIVED THE DEVICE FOR INVESTIGATION. TO DATE, THE PUMP IS UNDER INVESTIGATION. THEREFORE, ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT ABOUT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FAILING TO BOLUS DURING OR PREP. THE SCRUB NURSE EMPTIED 12 ML BACTERIOSTATIC WATER OFF THE PUMP AND WAS FILLED WITH 30ML HIGH-DOSE HEPARINIZED SALINE. THE SPECIAL BOLUS NEEDLE (SBN) WAS ATTACHED TO 10ML SYRINGE OF LOW-DOSE HEP SALINE: SCRUB NURSE ATTEMPTED TO FLUSH AS PER PROTOCOL THE CATHETER WOULD NOT FLUSH. A REPRESENTATIVE FROM INTERA ONCOLOGY VISUALLY CONFIRMED THAT THE SCRUB NURSE WAS MAKING CONTACT WITH THE NEEDLE STOPPER; THEN HAD THE SCRUB NURSE REMOVE THE SBN FROM PUMP SEPTUM AND CONFIRM THE PUMP WAS PATENT, SCRUB NURSE REATTEMPTED AND CATHETER WOULD NOT FLUSH. THE BACKUP SBN WAS OPENED, AND FLUSH WAS REATTEMPTED AND THE CATHETER WOULD NOT FLUSH. IT WAS DETERMINED THE BEST COURSE OF ACTION WAS TO OPEN AND PREP THE BACKUP PUMP. NO ISSUES WITH BACKUP PUMP PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588666 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 31683815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown