BEUDAMED
    FDA Adverse Event Death Summary report: N

    X-PORT ISP M.R.I. IMPLANTABLE PORT W/ATTACHABLE 8F GROSHONG

    MDR report key: 4151494 · Received October 6, 2014

    Report

    Report Number
    3006260740-2014-00496
    Event Type
    Death
    Date Received
    October 6, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    PMA / PMN Number
    K022983
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PORT SYSTEM WAS IMPLANTED IN A (B)(6)-YEAR-OLD FEMALE PATIENT VIA THE CEPHALIC VEIN CUTDOWN APPROACH FOR COLON CANCER CHEMOTHERAPY. AFTER PLACEMENT, THE CHEMOTHERAPY WAS DISCONTINUED DUE TO VOMITING. IN (B)(6) 2013, BLOOD ASPIRATION BECAME IMPOSSIBLE. AFTER THAT, THE PORT SYSTEM WAS SOMETIMES USED FOR IV BECAUSE FLUSHING WAS POSSIBLE. ON (B)(6) 2014, AN INTRAVENOUS INFUSION LINE WAS CONNECTED WITH THE PORT, AND THE PATIENT LEFT THE HOSPITAL. ON (B)(6) THE PATIENT'S CONDITION CHANGED SUDDENLY. THE DOCTOR ATTEMPTED RESUSCITATION, BUT THE PATIENT EXPIRED. AI CONFIRMED THE CATHETER TIP WAS PLACED IN THE CENTRAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623829 X-PORT ISP M.R.I. IMPLANTABLE PORT W/ATTACHABLE 8F GROSHONG LJT BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death