BEUDAMED
    FDA Enforcement Class II Terminated

    Safety monitor included with System 8000 Base 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. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.

    Recall: Z-2348-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2348-2012
    Event ID
    62321
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2012
    Initiation Date
    August 12, 2009
    Classification Date
    September 11, 2012
    Termination Date
    January 29, 2013
    Address
    6200 Jackson Road, N/A, Ann Arbor, MI, 48103-9586, United States

    Description

    Safety monitor included with System 8000 Base 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. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.

    Reason

    Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8 monitors were manufactured with an underrated circuit breaker due to an error where an associate pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory locations hav

    Code Info

    catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392.

    Distribution

    Worldwide distribution: International only-country of: Terumo Dubai, UAE

    Quantity

    8