BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    Recall: Z-0356-2009 · Initiated July 18, 2008

    Recall

    Recall Number
    Z-0356-2009
    Event Number
    44839
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 18, 2008
    Posted
    December 11, 2008
    Terminated
    July 7, 2009
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103

    Description

    Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    Reason

    Overspeed and underspeed errors, erratic pump behavior, jerky operation at low RPMs, pump instability, pump slowdowns and pump stops due to overspeed max events may occur due to a grease leak onto the motor speed encoder disk.

    Action

    Consignees were notified of the problem via recall letter dated 7/18/08. The firm began conducting field upgrades on the roller pumps in 07/08. For questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818.

    Distribution

    Worldwide Distribution including USA and countries of Australia, Belgium. Canada, Columbia, Dominican Republic, Egypt, Germany, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates and Viet Nam.

    Quantity

    269