BEUDAMED
    FDA Recall Terminated

    Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    Recall: Z-1321-2012 · Initiated March 16, 2012

    Recall

    Recall Number
    Z-1321-2012
    Event Number
    59573
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 16, 2012
    Posted
    March 27, 2012
    Terminated
    May 2, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    Reason

    Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery. There has been one report of the pump jamming during a case that concluded with an adverse patient outcome, although there was no indication that the pump jam contributed to the adverse patient outcome.

    Action

    "URGENT MEDICAL DEVICE RECALL" letters were sent on 3/16/12 to all consignees detailing the correction as well as also adding an Addendum to the Operator's manual for the Terumo System 1 to incorporate additional information and warnings for use when operating a 6" roller pump with dual-sized tubing. For questions call 1-800-521-2818.

    Distribution

    Worldwide Distribution--USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, Puerto Rico and the countries of INDIA, CANADA, CHILE, HONG KONG, EGYPT, PAKISTAN, KUWAIT, SAUDI ARABIA, JORDAN, UNITED ARAB EMIRATES, SOUTH AFRICA, SOUTH KOREA, PHILIPPINES, JAPAN, PHILIPPINES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, RUSSIA, TURKEY, BELGIUM, GERMANY, COLUMBIA, COSTA RICA, ARGENTINA, HONDURAS, COLUMBIA, DOMINICAN REPUBLIC, GUATEMALA, MEXICO, VIETNAM, and THAILAND.

    Quantity

    648 units