BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 19974049 · Received August 13, 2024

    Report

    Report Number
    3015537318-2024-00068
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 15, 2024
    Report Date
    September 10, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO INTERA ONCOLOGY AND IS CURRENTLY UNDERGOING BENCH TESTING TO ATTEMPT TO CONFIRM THE COMPLAINT ALLEGATION. SUPPLEMENT IS TO UPDATE THIS REPORT BASED ON BENCH TESTING PERFORMED BY INTERA. THE DEVICE DEMONSTRATED NORMAL FLOW INITIATION AND PASSED ALL FUNCTIONAL TESTS. THE COMPLAINT ALLEGATION WAS NOT OBSERVED DURING TESTING. THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THERE WERE NO NONCONFORMANCES RELATED TO THIS SERIAL NUMBER. THE DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS PRIOR TO RELEASE FROM MANUFACTURING. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED TO INTERA ONCOLOGY AND IS CURRENTLY UNDERGOING BENCH TESTING TO ATTEMPT TO CONFIRM THE COMPLAINT ALLEGATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE TESTING. THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THERE WERE NO NONCONFORMANCE'S RELATED TO THIS SERIAL NUMBER. THE DEVICE PASSED ALL FUNCTIONAL AND PERFORMANCE TESTS PRIOR TO RELEASE FROM MANUFACTURING.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A HEALTHCARE PROVIDER THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FAILED TO FLOW DURING OR PREP PRIOR TO IMPLANTATION. THE HEALTHCARE PROVIDER REPORTED THAT THEY ATTEMPTED THE TROUBLESHOOTING STEPS PROVIDED IN THE IFU FOR THE DEVICE BUT WERE STILL NOT ABLE TO INITIATE FLOW. THEY WERE ABLE TO PREP AND IMPLANT A SECOND DEVICE BUT THE SURGERY WAS DELAYED.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT FROM A HEALTHCARE PROVIDER THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FAILED TO FLOW DURING OR PREP PRIOR TO IMPLANTATION. THE HEALTHCARE PROVIDER REPORTED THAT THEY ATTEMPTED THE TROUBLESHOOTING STEPS PROVIDED IN THE IFU FOR THE DEVICE BUT WERE STILL NOT ABLE TO INITIATE FLOW. THEY WERE ABLE TO PREP AND IMPLANT A SECOND DEVICE BUT THE SURGERY WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683518 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 29002622 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention