BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 19336816 · Received May 16, 2024

    Report

    Report Number
    3015537318-2024-00049
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    December 4, 2023
    Report Date
    August 12, 2024
    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 HAS BEEN REQUESTED TO RETURN TO INTERA FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED. UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE DHR FOR THIS SERIAL NUMBER WAS REVIEWED. THERE WAS THREE DEVIATIONS RELATED TO THE SIZE OF THE CONTAINER OF SILICONE ADHESIVE USED IN THE MANUFACTURING PROCESS. THE SIZE OF THE CONTAINER WAS DETERMINED TO HAVE NO IMPACT ON THE FUNCTION AND PERFORMANCE OF THE DEVICE. THERE WERE NO NONCONFORMANCES RELATED TO THIS SERIAL NUMBER; THE DEVICE MET ALL FUNCTIONAL AND PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE INVOLVED IN THIS COMPLAINT WAS RETURNED TO INTERA AND EVALUATED UNDER TEST PROTOCOL FOR PERFORMANCE. IN SUMMARY, THE DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS: VISUAL, RESERVOIR EVACUATION, FLOW, INADVERTENT BOLUS, AND PRESSURE/VOLUME. NO DEVICE DEFICIENCY WAS NOTED OR DETECTED. THEREFORE, THE COMPLAINT OF SLOW FLOW/NO FLOW PERTAINING TO A DEVICE MALFUNCTION WAS NOT CONFIRMED. SUPPLEMENTAL REPORT TO ADD PATIENT DEMOGRAPHIC INFORMATION. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT A PATIENT WITH AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS EXPERIENCING LOWER THAN EXPECTED FLOW RATE. THE DEVICE WAS IMPLANTED (B)(6) 2023 AT ONE HEALTHCARE FACILITY, BUT WAS RECEIVING REFILL INFUSIONS AT A SECOND HEALTHCARE FACILITY IN A DIFFERENT STATE. THE REFILL INTERVALS FOR THE DEVICE AT THE SECOND HEALTHCARE FACILITY WAS REPORTED AS FOLLOWS: (B)(6) 2023 - FLOW RATE CALCULATED TO BE 1.21 ML/D. (B)(6) 2023 - FLOW RATE CALCULATED TO BE 1.14 ML/D. (B)(6) 2023 FLOW RATE CALCULATED TO BE 1.07 ML/D. (B)(6) 2023 - FLOW RATE CALCULATED TO BE 0.71 ML/D. (B)(6) 2023 - FLOW RATE CALCULATED TO BE 0.78 ML/D (B)(6) 2024 - NOTHING WAS RETURNED FROM THE DEVICE. IT WAS STATED THAT THE PATIENT WAS NOT AT THE FACILITY BETWEEN DECEMBER AND FEBRUARY, AND IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN TRAVELING OVERSEAS AT THAT TIME. (B)(6) 2024 - FLOW RATE CALCULATED TO BE 1.0 ML/D. (B)(6) 2024 - FLOW RATE CALCULATED TO BE 1.14 ML/D. (B)(6) 2024 - 30 ML OF HEP SALINE RETURNED DURING REFILL PROCEDURE. (B)(6) 2024 - 30 ML OF HEP SALINE RETURNED DURING REFILL PROCEDURE. THERE WAS NO NOTES FROM THE SECOND HEALTHCARE FACILITY REGARDING USE OF THE SPECIAL BOLUS NEEDLE OR NUCLEAR MEDICING/IR NOTES PERTAINING TO A FLOW STUDY TO CONFIRM CATHETER PATENCY. THE PATIENT RETURNED TO THE FIRST HEALTHCARE FACILITY, AND HAD THE DEVICE EXPLANTED AND REPLACED ON (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT A PATIENT WITH AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WAS EXPERIENCING LOWER THAN EXPECTED FLOW RATE. THE DEVICE WAS IMPLANTED (B)(6) 2023 AT ONE HEALTHCARE FACILITY BUT WAS RECEIVING REFILL INFUSIONS AT A SECOND HEALTHCARE FACILITY IN A DIFFERENT STATE. THE REFILL INTERVALS FOR THE DEVICE AT THE SECOND HEALTHCARE FACILITY WAS REPORTED AS FOLLOWS: O (B)(6)2023 - FLOW RATE CALCULATED TO BE 1.21 ML/D O (B)(6)2023 - FLOW RATE CALCULATED TO BE 1.14 ML/D O (B)(6)2023 FLOW RATE CALCULATED TO BE 1.07 ML/D O (B)(6)2023 - FLOW RATE CALCULATED TO BE 0.71 ML/D O (B)(6)2023 - FLOW RATE CALCULATED TO BE 0.78 ML/D O (B)(6)2024 - NOTHING WAS RETURNED FROM THE DEVICE. IT WAS STATED THAT THE PATIENT WAS NOT AT THE FACILITY BETWEEN (B)(6), AND IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN TRAVELING OVERSEAS AT THAT TIME. O (B)(6)2024 - FLOW RATE CALCULATED TO BE 1.0 ML/D O (B)(6)2024 - FLOW RATE CALCULATED TO BE 1.14 ML/D O (B)(6)2024 - 30 ML OF HEP SALINE RETURNED DURING REFILL PROCEDURE O 4(B)(6)2024 - 30 ML OF HEP SALINE RETURNED DURING REFILL PROCEDURE THERE WAS NO NOTES FROM THE SECOND HEALTHCARE FACILITY REGARDING USE OF THE SPECIAL BOLUS NEEDLE OR NUCLEAR MEDICING/IR NOTES PERTAINING TO A FLOW STUDY TO CONFIRM CATHETER PATENCY. THE PATIENT RETURNED TO THE FIRST HEALTHCARE FACILITY, AND HAD THE DEVICE EXPLANTED AND REPLACED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381573 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 29157 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R