BEUDAMED
    FDA Recall Terminated

    Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100.

    Recall: Z-2684-2011 · Initiated April 21, 2011

    Recall

    Recall Number
    Z-2684-2011
    Event Number
    58532
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DRY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 21, 2011
    Posted
    June 28, 2011
    Terminated
    August 6, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100.

    Reason

    Inaccurate readings may result after Methylene Blue, an intravascular dye, is administered to the patient. The presence of Methylene Blue may interfere with the readings from the shunt sensor for the CDI 500 system in a way that would cause inaccurate pH values. Because the pH value is used to calculate other values, these parameters could also be affected by the presence of Methylene Blue: K

    Action

    Terumo sent URGENT MEDICAL DEVICE CORRECTION letters to Chief of Perfusion, Department of Cardiothoracic Surgery or Director of Operating Room Services, dated 4/21/2011. The letter explained the reason for the correction and the potential hazard. The letter stated that Terumo was updating the Operators Manual for all CDI systems and would provide the manuals to all users when available. Consignees with questions should call 1-800-521-2818. Monday- Friday 8 am- 6 pm.

    Distribution

    Worldwide distribution, including USA, Australia, Barbados, BELGIUM, BRAZIL, CANADA, Chile, Colombia, Costa Rica, Dominican Republic, ECUADOR, El Salvador, France, Germany, Guatemala, Holland, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Korea, Libya, MALAYSIA, MEXICO, PAKISTAN, PANAMA, Paraguay, Saudi Arabia, SINGAPORE, South Africa, Spain, TAIWAN, THAILAND, The Phillipines, TRINIDAD, UNITED ARAB EMIRATES, Uruguay, Venezuela and Vietnam.

    Quantity

    1193