BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASCULAR PORT

    MDR report key: 2440655 · Received January 3, 2012

    Report

    Report Number
    2440655
    Event Type
    Death
    Date Received
    January 3, 2012
    Date of Event
    November 15, 2011
    Report Date
    November 25, 2011
    Manufacturer
    PFM MEDICAL
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO A NEIGHBORING HOSPITAL WITH C/O DIFFUSE PAIN, DECREASED PO INTAKE. HE HAD BEEN UNDERGOING PALLIATIVE CHEMO WITH CARBOPLATIN AND TAXOL. TREATMENT HAD BEEN STOPPED ONE WEEK PRIOR TO THIS ADMISSION DUE TO RECURRENT HOSPITAL ADMISSION WITH DEHYDRATION AND UTI'S. IT WAS DETERMINED HE HAD A UTI AN WAS BEING TREATED. WHEN IT WAS DISCOVERED IT WAS UROSEPSIS HE WAS TRANSFERRED TO (B)(6). PATIENT'S BLOOD CULTURES CONTINUED TO GROW (B)(6) DESPITE BEING ON VANCOMYCIN SINCE (B)(6) 2011. THE DECISION WAS MADE TO REMOVED THE PORTACATH BECAUSE OF IT WAS THOUGHT THIS WAS A SOURCE OF INFECTION. THE PORTACATH WAS REMOVED UNDER LOCAL ANESTHESIA. WHEN THE SURGEON MADE THE INCISION NEAR THE PORT SITE, HE ENCOUNTERED A POCKET OF PURULENT MATERIAL WHICH WAS CULTURED. THE TIP OF THE CATHETER FROM NEARLY 5CM HAD A FIBRINOUS EXUDATE AS WELL AS CONTAINING INFLAMED LOOKING EXUDATE AS WELL ACCORDING TO THE SURGEON'S OP NOTE. THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL. THE PATIENT HAD A RRT CALLED ON (B)(6) 2011 AND CT OF CHEST WAS DONE AND PATIENT TRANSFERRED TO ICU. PATIENT INTUBATED AND MECHANICAL VENTILATION BUT DESPITE CPR ON (B)(6) 2011 THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCULAR PORT VENOUS ACCESS DEVICE LJT PFM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L