BEUDAMED
    FDA Recall Terminated

    Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500

    Recall: Z-2233-2012 · Initiated July 26, 2012

    Recall

    Recall Number
    Z-2233-2012
    Event Number
    62684
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 26, 2012
    Posted
    August 21, 2012
    Terminated
    June 27, 2014
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500

    Reason

    Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu

    Action

    Terumo sent an URGENT MEDICAL DEVICE Recall letter dated July 24, 2012 to all affected customers. The letter identified the affected product, reason for correction, potential hazard and actions to be taken. The letter stated that Terumo CVS will replace all affected modules. Customers were informed that a Terumo VS Representative will contact the user to schedule a service call for the replacement upon receipt of the Response Form attached. For questions contact Terumo CVS Customer Service at 800-521-2818.

    Distribution

    Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam

    Quantity

    582 units