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.

Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limi

Terumo Cardiovascular Systems sent a Urgent Medical Device Recall Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Terumo CVS is alerting all users of Terumo System 1 of the reports of malfunction. Customers were instructed to: 1. Review this Medical Device Safety Advisory. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/email address indicated on the form. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818, Recall Fax 1-734-741-6149 Customer Service Hours: Monday thru Friday, 8 AM - 6 PM ET