BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL LINE

    MDR report key: 1190143 · Received September 26, 2008

    Report

    Report Number
    1190143
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 30, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ALSIUS CORPORATION
    Product Code
    NCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    12 HOURS AFTER INSERTION SALINE FROM THE MACHINE WAS NOTED TO BE LEAKING AROUND THE SUBCLAVIAN CATHETER SITE. THE CATHETER WAS REMOVED. THE HEAT EXCHANGE MACHINE WAS SEQUESTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL LINE CATHETER, THERMAL REGULATION NCX ALSIUS CORPORATION 601038-001 19569 OR 19463
    2 COOLGARD 3000 TEMPERATURE CONTROL UNIT NCX ALSIUS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR