BEUDAMED
    FDA Recall Terminated

    System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

    Recall: Z-2178-2012 · Initiated July 26, 2012

    Recall

    Recall Number
    Z-2178-2012
    Event Number
    62444
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 26, 2012
    Posted
    August 9, 2012
    Terminated
    November 16, 2012
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

    Reason

    Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re

    Action

    The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 26, 2012 to its customers. The letter described the product, problem and actions to be taken. To customers were instructed to review this Medical Device Recall notice and addendum; assure that all users are aware of this notice and addendum; place the addendum in the front of Section 7: Modules (p 7.1) and confirm receipt of this communication by faxing the attached Customer Response Form to the fax number/email address indicated on form. Terumo CVS is issuing a Safety Advisory to alert all Terumo System 1 users of the potential for failure and providing an addendum for the Operator Manual with instruction on how to respond to the failure. If you have any question or concerns contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are Monday-Friday, 8AM - 6PM ET.

    Distribution

    Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

    Quantity

    649 units