BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20239745 · Received September 17, 2024

    Report

    Report Number
    3015537318-2024-00080
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 17, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO OUR UNDERSTANDING, THE INTERA 3000 HAI PUMP REMAINS IMPLANTED ON THE PATIENT. INTERA ONCOLOGY HAS ATTEMPTED A MINIMUM OF THREE ATTEMPS TO SEEK ADDITIONAL INFORMATION, SUCH AS THE SERIAL NUMBER AND OTHER, FROM CLINIC. TO DATE, NO RESPONSE HAS BEEN RECEIVED. THE CAUSES OF THIS INCIDENT ARE INCONCLUSIVE. THEREFORE, ONCE WE OBTAIN UPDATED INFORMATION, WE'LL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT A NURSE ON AUGUST 26, 2024 WAS UNABLE TO ACCESS THE PUMP. DUE TO THIS THE NURSE SENT THE PATIENT HOME. ON AUGUST 27, 2024, ANOTHER NURSE ASSISTED THE PATIENT. THE NURSE MENTIONED THAT SHE WAS POSITIVE THAT THE NEEDLE WAS IN THE CORRECT POSITION. HOWEVER, SHE COULD NOT PUSH SALINE INTO THE PUMP TO CONFIRM PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761285 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H UNKNOWN 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown