BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 23361501 · Received October 22, 2025

    Report

    Report Number
    3015537318-2025-00097
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    January 20, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    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 DEVICE WAS EVALUATED IN HOUSE. THE COMPLAINT FOR THE PUMP BEING UNABLE TO BOLUS COULD NOT BE REPLICATED.

    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) 2025, INTERA ONCOLOGY SHIPPED A RETURN KIT TO THE PHYSICIAN OFFICE TO RETRIEVE THE ACTUAL DEVICE FOR EXAMINATION. TO DATE, THE PUMP HAS NOT BEEN RETURNED. THEREFORE, ONCE WE RECEIVE THE PUMP AND IT'S EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING PUMP PREPARATION, THE NURSE REPORTED HAVING NO ISSUES EMPTYING AND REFILLING THE PUMP WITH 30 ML OF HIGH-DOSE HEPARINIZED SALINE (1000 IU/ML). HOWEVER, UPON ACCESSING THE PUMP SEPTUM WITH THE SPECIAL BOLUS NEEDLE (SBN), THE NURSE WAS UNABLE TO INJECT 5 ML, AND NO FLUID EXITED FROM THE CATHETER TIP. IT WAS CONFIRMED THAT THE NEEDLE WAS UNCLAMPED AND ATTEMPTED AGAIN WITH THE SAME RESULT. A SECOND ATTEMPT WAS MADE BY USING THE BACKUP SBN NEEDLE AND WAS UNSUCCESSFUL. THE CLINIC THEN PROCEEDED TO OPEN THE BACKUP PUMP (B)(6), WHERE EMPTYING, FILLING, AND FLUSHING WERE COMPLETED WITHOUT ISSUE.

    Description of Event or Problem · 0

    DURING PUMP PREPARATION, THE NURSE REPORTED HAVING NO ISSUES EMPTYING AND REFILLING THE PUMP WITH 30 ML OF HIGH-DOSE HEPARINIZED SALINE (1000 IU/ML). HOWEVER, UPON ACCESSING THE PUMP SEPTUM WITH THE SPECIAL BOLUS NEEDLE (SBN), THE NURSE WAS UNABLE TO INJECT 5 ML, AND NO FLUID EXITED FROM THE CATHETER TIP. IT WAS CONFIRMED THAT THE NEEDLE WAS UNCLAMPED AND ATTEMPTED AGAIN WITH THE SAME RESULT. A SECOND ATTEMPT WAS MADE BY USING THE BACKUP SBN NEEDLE AND WAS UNSUCCESSFUL. THE CLINIC THEN PROCEEDED TO OPEN THE BACKUP PUMP (19915), WHERE EMPTYING, FILLING, AND FLUSHING WERE COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504659 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 29002622 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown