BEUDAMED
    FDA Recall Terminated

    System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.

    Recall: Z-2736-2011 · Initiated March 31, 2011

    Recall

    Recall Number
    Z-2736-2011
    Event Number
    58547
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 31, 2011
    Posted
    July 6, 2011
    Terminated
    August 28, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    System 1 Base 220V, Catalog 801764, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.

    Reason

    The firm has received multiple reports of the lower roller pump tube clamp mechanism failing to function in a small population of devices, making it difficult to remove or insert the tubing. If the failure occurs, the clamp dial will no longer be able to control opening/closing of the tube clamp mechanism.

    Action

    Terumo Cardiovascular Systems sent an URGENT MEDICAL DEVICE CORRECTION letter to all affected customers dated March 21, 2011. The letter identified the product, the problem and the action needed to be taken by the customer. An additional URGENT MEDICAL DEVICE RECALL correction notification and cover letter was sent to all consignees on XX/XX/XX to explain the reason for the expansion of the recall and will provide an update to the timing of implementation of the field correction. Expansion now includes devices manufactured between 2006 and March 2012. The correction strategy is to issue the customers a letter and addendum to the Operator's Manual that specifies what the user should do in the event of a tube clamp failure for any reason. The letter states that the firm is still investigating the issue and the correction. The letter states that in the coming months when a resolution is identified, consignees may be contacted to make arrangements for a upgrade to the system. There is no specific timeline for the correction to be made. If you have any further questions, please call a Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours Monday - Friday, 8 Am - 6 Pm EST.

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of Argentina, Australia, Belgium, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Japan, Jordan, Korea, Kuwait, Malaysia, Mexico, Pakistan, Republic of Georgia, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, The Phillipines, Turkey, United Arab Emirates and Vietnam.

    Quantity

    596 devices.