BEUDAMED
    FDA Recall Terminated

    Perfusion System 8000, base 5 pump, 220V/240V 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-0129-2013 · Initiated September 25, 2012

    Recall

    Recall Number
    Z-0129-2013
    Event Number
    62315
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 25, 2012
    Posted
    October 24, 2012
    Terminated
    August 21, 2015
    Address
    6200 Jackson Rd, Ann Arbor, MI, 48103-9586

    Description

    Perfusion System 8000, base 5 pump, 220V/240V 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 power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction

    Action

    TERUMO sent an URGENT MEDICAL DEVICE letter dated September 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed review the Medical Device Recall notice, assure that all users are aware of the notice and place the addendum in the Operator's Manual before page 1.13. Customers were also instructed to confirm receipt of the Urgent Medical Device letter by faxing, the attached Customer Response Form to 1-800-292-6551. For questions customers were instructed to call 1-800-521-2818.

    Distribution

    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, CALLO PERU, CANADA, CAROLINA PR, CHILE, China, COLOMBIA, Costa Rica, DEKALB, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, Germany, GUAYQUIL ECUADOR, Hong Kong, India, Indonesia, ITALY, Japan, , JARAMA MADRID, Lebanon, LEICESTERSHIRE, MADRID SPAIN, MADRID SPAIN, Malaysia, MEDLEY, Mexico, D.F., MIAMI, MUMBAI 26 INDIA, MUMBAI, New Zealand, Nicaragua, Pakistan, Panama, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, SELANGOR, MALAYSA, SEOUL, KOREA, Singapore, SOUTH AFRICA, South Korea, Sri Lanka, SWITZERLAND, TAIPEI, TAIWAN, Thailand, TUJUNGA, UNITED ARAB EMIRATES (UAE), URUGUAY, Venezuela, Vietnam, VIGNATE ITALY, WOODDALE, and Yemen.

    Quantity

    312 units