BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20014173 · Received August 21, 2024

    Report

    Report Number
    3015537318-2024-00070
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 22, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    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 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.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FAILED TO FLOW DURING OR PREP PRIOR TO IMPLANTATION. AN INTERA CLINICAL SPECIALIST WAS ON SITE TO ASSIST WITH THE CASE BUT WAS UNABLE TO INITIATE FLOW IN THE DEVICE AFTER PERFORMING THE TROUBLESHOOTING STEPS. THEY WERE ABLE TO PREP AND IMPLANT A SECOND DEVICE BUT THE SURGERY WAS DELAYED. THE CLINICAL SPECIALIST REPORTED THAT A SECOND FLUID WARMER WAS USED FOR THE SECOND PUMP AND THAT THE INITIAL PUMP WAS ABLE TO FORM A BEAD WHEN PLACED IN THE SECOND FLUID WARMER, INDICATING THAT THERE MAY HAVE BEEN AN ISSUE WITH THE INITIAL FLUID WARMER.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP FAILED TO FLOW DURING OR PREP PRIOR TO IMPLANTATION. AN INTERA CLINICAL SPECIALIST WAS ON SITE TO ASSIST WITH THE CASE BUT WAS UNABLE TO INITIATE FLOW IN THE DEVICE AFTER PERFORMING THE TROUBLESHOOTING STEPS. THEY WERE ABLE TO PREP AND IMPLANT A SECOND DEVICE BUT THE SURGERY WAS DELAYED. THE CLINICAL SPECIALIST REPORTED THAT A SECOND FLUID WARMER WAS USED FOR THE SECOND PUMP AND THAT THE INITIAL PUMP WAS ABLE TO FORM A BEAD WHEN PLACED IN THE SECOND FLUID WARMER, INDICATING THAT THERE MAY HAVE BEEN AN ISSUE WITH THE INITIAL FLUID WARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151637 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 29287 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention