BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRELLIS 8 120X30

    MDR report key: 1671940 · Received April 28, 2010

    Report

    Report Number
    2953724-2010-00107
    Event Type
    Death
    Date Received
    April 28, 2010
    Date of Event
    April 21, 2010
    Report Date
    April 21, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B) (6) 2010, THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER, CONTINUOUS FLOW. THE CUSTOMER REPORTS THAT THEY WERE USING THE TRELLIS ON A PT. THEY PERFORMED TWO RUNS, REMOVED THE DEVICE, SHOT A VENOGRAM, AND WERE REINTRODUCING AN INFUSION CATHETER WHEN THE PT WENT INTO RESPIRATORY DISTRESS AND EXPIRED. CUSTOMER REPORTS THAT THIS PT WAS IN DNR STATUS AND NO RESUSCITATION WAS ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRELLIS 8 120X30 CATHETER, CONTINUOUS FLOW KRA COVIDIEN BVT812030 P0930057

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death