BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 22793999 · Received August 13, 2025

    Report

    Report Number
    3015537318-2025-00069
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 9, 2025
    Report Date
    December 23, 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
    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. WHEN THE PUMP WAS FIRST RETURNED TO INTERA, IT COULD NOT BOLUS AND THE COMPLAINT WAS CONFIRMED. THE BOLUS NEEDLE WAS REPOSITIONED MULTIPLE TIMES AND STILL COULD NOT BOLUS. A CT SCAN WAS PERFORMED, AND NO INDICATION OF MALFUNCTION WAS EVIDENT. AFTER THE PUMP RETURNED FROM THE CT SCAN, IT WAS ABLE TO BOLUS NORMALLY. IT IS UNCLEAR WHAT CAUSED THE PUMP TO THEN BE ABLE TO BOLUS.

    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 IS WAITING FOR THE PUMP TO ARRIVE TO BEGIN THE INVESTIGATION. ONCE THE PUMP ARRIVES AND IS FULLY INVESTIGATED, A SUPPLEMENTAL REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SCRUB TECH ATTEMPTED TO PREP A PUMP. THE SOLUTION WARMER WAS ON, HEATED TO 120°F, AND THE PUMP WAS PLACED IN THE WARMER. THE SCRUB TECH EMPTIED THE PUMP AND AFTER THAT FILLED THE PUMP. THE SCRUB TECH ATTEMPTED TO FLUSH THE CATHETER PATHWAY USING THE SPECIAL BOLUS NEEDLE (SBN) BUT WAS UNABLE TO FLUSH THREE TIMES. THE NEEDLE WAS REMOVED AND REINSERTED THREE TIMES. THE SCRUB TECH CONFIRMED THE NEEDLE WAS PRIMED AND UNCLAMPED. LATER, THE SCRUB TECH ATTEMPTED THE SAME STEPS USING THE EXTRA SBN FROM THE PUMP THREE TIMES AND DID NOT FLUSH. DUE TO THIS A NEW PUMP WAS OPENED AND PREPPED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A SCRUB TECH ATTEMPTED TO PREP A PUMP. THE SOLUTION WARMER WAS ON, HEATED TO 120°F, AND THE PUMP WAS PLACED IN THE WARMER. THE SCRUB TECH EMPTIED THE PUMP AND AFTER THAT FILLED THE PUMP. THE SCRUB TECH ATTEMPTED TO FLUSH THE CATHETER PATHWAY USING THE SPECIAL BOLUS NEEDLE (SBN) BUT WAS UNABLE TO FLUSH THREE TIMES. THE NEEDLE WAS REMOVED AND REINSERTED THREE TIMES. THE SCRUB TECH CONFIRMED THE NEEDLE WAS PRIMED AND UNCLAMPED. LATER, THE SCRUB TECH ATTEMPTED THE SAME STEPS USING THE EXTRA SBN FROM THE PUMP THREE TIMES AND DID NOT FLUSH. DUE TO THIS A NEW PUMP WAS OPENED AND PREPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63104 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 29697757 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown