BEUDAMED
    FDA Recall Terminated

    Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    Recall: Z-0284-2013 · Initiated September 25, 2012

    Recall

    Recall Number
    Z-0284-2013
    Event Number
    62733
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 25, 2012
    Posted
    November 13, 2012
    Terminated
    July 11, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardio

    Action

    The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" notice/Safety Advisory Alert dated September 24, 2012 and an addendum to the Operator's Manual to alert all affected Customers. The notice described the product, problem and actions to be taken. The customers were instructed to review this medical device recall notice; assure that all users are aware to this notice; place the addendum in the Operator's Manual just before page 4.1 and complete and return the attached Customer Response Form via Fax to: 1-734-741-6149 or email to:www.termuo-cvs.com. If you have any questions or concerns contact Terumo CVS Customer Service at 1-800-521-1818; Monday - Friday, 8 AM - 6 PM ET.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).

    Quantity

    26