BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANKETROL III, HOSE

    MDR report key: 2840336 · Received November 17, 2012

    Report

    Report Number
    1516825-2012-00004
    Event Type
    Malfunction
    Date Received
    November 17, 2012
    Date of Event
    August 18, 2012
    Report Date
    September 20, 2012
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC.
    Product Code
    DWJ
    PMA / PMN Number
    101589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT/UFR DATA INDICATED THAT THE CSZ HOSE WAS LEAKING. INITIAL EVAL OF THE HOSE FROM SAME LOT CONFIRMED THE LEAK AT THE HANSEN SOCKET END. HOSE IS A WARE ITEM AND MUST BE CHECKED FREQUENTLY FOR LEAKS AND REPLACED IF NECESSARY. CSZ IS FURTHER INVESTIGATING THE HOSE FAILURE FOR THE ROOT CAUSE AND POSSIBLE F/U ACTIONS. CSZ BELIEVES HOSE LEAK IS AN EASILY RECOGNIZABLE ISSUE THAT COULD HAVE BEEN IDENTIFIED PRIOR TO USE OF DEVICE. WHILE CSZ FURTHER INVESTIGATE THE ROOT CAUSE OF THE HOSE LEAK, THE USER HAS BEEN INFORMED OF FOLLOWING THE "WARNING" PROVIDED IN THE OPERATIONS AND TECHNICAL MANUAL FOR TAKING THE PRECAUTIONS IN CASE A WATER LEAK IS FOUND INTO OR AROUND THE DEVICE. IN ADDITION, THE USER HAS ALSO BEEN INFORMED TO FOLLOW REQUIRED QUARTERLY PREVENTIVE MAINTENANCE PROCEDURE OF THE DEVICE THAT INCLUDES CHECKING ALL HOSES, COUPLINGS, SOCKETS, AND CONNECTIONS FOR ANY WATER LEAKS. AS SOON AS THE INVESTIGATION IS COMPLETED, SUPPLEMENTAL MDR WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    PT UNDERGOING HYPOTHERMIA THERAPY AND BLANKETROL WAS LEAKING WATER FROM HOSES. HOSE CONNECTIONS WERE DISCONNECTED AND RECONNECTED. HOSE CONTINUE TO LEAK ACTIVELY AT THE SITE WHERE THE COUPLING AND HOSE MET. A NEW HOSE WAS ORDERED AND SWAPPED OUT FOR THE LEAKING HOSE. NO FURTHER LEAKING NOTED FROM UNIT AFTER THE HOSE WAS CHANGED. PT'S TEMPERATURE HAS BEEN IN DESIRED RANGE. MORE WATER WAS ADDED TO THE BLANKETROL TO REPLACE WHAT WAS LOST. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANKETROL III, HOSE SYSTEM, THERMAL REGULATING DWJ CINCINNATI SUB-ZERO PRODUCTS, INC. 286 10755

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other