BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURAFLOW CVC

    MDR report key: 1763428 · Received May 21, 2010

    Report

    Report Number
    1763428
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT'S INDWELLING DURAFLOW CATHETER SEPARATED AT THE VENOUS PORT JUNCTION OF THE PT'S PORTION OF THE CATHETER DURING DIALYSIS. ALARM SOUNDED ON DIALYSIS MACHINE. PT WAS UNRESPONSIVE. RESUSCITATION WAS INITIATED WITH VITAL SIGNS PRESENT. EMS ARRIVED AND TOOK OVER RESUSCITATION MEASURES AND TRANSPORTED THE PT TO (B) (6) HOSPITAL MEDICAL CENTER. THE FACILITY WAS NOTIFIED THAT THE PT WAS PRONOUNCED DEAD AT (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAFLOW CVC DIALYSIS CATHETER MSD ANGIODYNAMICS 10301202

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death