BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOME TITANIUM SINGLE LUMEN PORT

    MDR report key: 2913060 · Received November 30, 2012

    Report

    Report Number
    2913060
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 30, 2012
    Manufacturer
    C.R. BARD INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    TEN MINUTES AFTER INITIATING IV FLUIDS VIA THE PATIENT'S INFUSAPORT THE PATIENT TOUCHES HER CHEST OVER HER HEART AND REPORTS NOT FEELING WELL. AUSCULTATING HER HEART TONES SHOWS RAPID BURSTS OF HEART BEAT INTERMITTENTLY WITH IRREGULAR RHYTHM. THE PATIENT DENIES CHEST PAIN, SOB, AND DIZZINESS AND IS NOT DIAPHORETIC. EKG DONE. PALPITATIONS PERSIST THROUGHOUT THE DAY. CHEMOTHERAPY IS GIVEN VIA PERIPHERAL SITE. AT THE COMPLETION OF HER TREATMENT THE PATIENT GOES TO RADIOLOGY AND A CHEST X-RAY REVEALS THAT THE INFUSAPORT HAD DETACHED AND MIGRATED INTO HER HEART" THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY AND THE DEVICE WAS REMOVED. THIS IS THE THIRD SIMILAR OCCURRENCE THIS YEAR. THE DEVICE WAS IMPLANTED 2 YEARS AGO. THE BREAK WAS ON THE DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOME TITANIUM SINGLE LUMEN PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD INC. 0602850 REUJ0026

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention CHEMOTHERAPY