BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20169444 · Received September 9, 2024

    Report

    Report Number
    3015537318-2024-00074
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 12, 2024
    Report Date
    November 7, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF TESTING. THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED. THERE WAS 1 NONCONFORMANCE RELATED TO THIS MANUFACTURING LOT. AN AUTOCLAVE USED TO PERFORM STRESS TESTING WAS NOT CALIBRATED ON TIME. THE AUTOCLAVE MET ALL SPECIFICATIONS WHEN CALIBRATED AND IS OPERATING AS INTENDED. THIS NONCONFORMANCE HAS NO IMPACT ON THE DEVICE. THE DEVICE MET ALL SPECIFICATIONS 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. 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 WAS 1 NONCONFORMANCE RELATED TO THIS MANUFACTURING LOT. AN AUTOCLAVE USED TO PERFORM STRESS TESTING WAS NOT CALIBRATED ON TIME. THE AUTOCLAVE MET ALL SPECIFICATIONS WHEN CALIBRATED AND IS OPERATING AS INTENDED. THIS NONCONFORMANCE HAS NO IMPACT ON THE DEVICE. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF ADDITIIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 TROUBLESHOOTING STEPS 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 TROUBLESHOOTING STEPS 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
    1537584 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28521740 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention