BEUDAMED
    FDA Enforcement Class II Terminated

    System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 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-2056-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2056-2012
    Event ID
    61242
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    June 22, 2012
    Classification Date
    July 20, 2012
    Termination Date
    March 6, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586, United States

    Description

    System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 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) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application

    Code Info

    catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, and 1100-1429.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

    Quantity

    640 devices