BEUDAMED
    FDA Recall 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 · Initiated August 12, 2009

    Recall

    Recall Number
    Z-2348-2012
    Event Number
    62321
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 12, 2009
    Posted
    September 11, 2012
    Terminated
    January 29, 2013
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    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

    Action

    TERUMO Cardiovascular Systems communicated with their affiliate, Terumo Dubai, in 2009 at the time the complaints were reported. No further communication was warranted. For questions regarding this recall call 734-741-6173.

    Distribution

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

    Quantity

    8