Class 2 Device Recall Terumo Advanced Perfusion System 1

• Date Initiated by Firm: February 14, 2011
• Date Posted: March 07, 2011
• Recall Status: Terminated on March 20, 2012
• Recall Number: Z-1566-2011
• Recall Event ID: 57969
• 510(K)Number: K022947
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
• Code Information: serial numbers 0011-0610, 1001-1182.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Road; Ann Arbor MI 48103-9586
• For Additional Information Contact: 734-741-6173
• Manufacturer Reason for Recall: Terumo Cardiovascular Systems (CVS) has received 19 reports of a circuit breaker for the Terumo Advanced Perfusion System 1 tripping and causing the system to switch to battery back-up power. In two cases, the incident was caused when the circuit breaker came into incidental contact with the base of an IV pole; in others there was no known cause. Terumo CVS' investigation has determined that
• FDA Determined Cause: Device Design
• Action: Terumo sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 14, 2011, addressed to Chief of Perfusion, Department of Cardiovascular Surgery or Director of Operationd Room Services. The letter explains the problem with the circuit breakers and hazards of the problem. The letter states that a service technician will visit the facility to install a guard. The service will be performed at the next scheduled preventative maintenance visit for those consignees with a service contract. For customers without a service contract, Terumo CVS will contact the consignees to schedule an appointment for the correction. Customers were instructed to review the Medical Device Correction notice. Assure that all users are aware of the notice. Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form. For questions or concerns customers were instructed to contact Terumo CVS Customer Service at 1-800-521-2818.
• Quantity in Commerce: 728 devices.
• Distribution: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, ME, MI, MO, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WV and the countries of CANADA, COLUMBIA, JAPAN, RUSSIA, EGYPT, TURKEY, PAKISTAN, KUWAIT, COSTA RICA, TAIWAN, SAUDI ARABIA, INDIA, SOUTH KOREA, JORDAN, THE PHILLIPINES, INDONESIA, HONDURAS, DOMINICAN REPUBLIC, REPUBLIC OF GEORGIA, HONG KONG, UNITED ARAB EMIRATES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, GERMANY, BELGIUM, MEXICO, THAILAND, VEITNAM, SOUTH AFRICA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DTQ