100/120V AC, Advanced Perfusion System Platform (APS) 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.

On 5/1/2015 Terumo issued an URGENT MEDICAL DEVICE CORRECTION letter to users explaining that Terumo has identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a phased approach beginning late 2015: - Implementing design changes and upgrades to improve the reliability of power switching and battery backup. - Adding a switch protector to the On/Off power switch to prevent inadvertent shut off. - Replacing the On/Off power switch with a new design to prevent switch failure. A Terumo Field Service Representative will contact users to schedule the field correction activities once the activities are ready to be implemented. CUSTOMER INSTRUCTIONS: Review this Medical Device Correction and assure that all users have received notice of this issue. - Complete and return the enclosed Customer Response Form. - Terumo CVS will contact users to schedule the field correction activities. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818 Fax 1-734-741-6149 Customer Service Hours: Monday Friday, 8 a.m. 6 p.m. ET