Class 2 Device Recall Perfusion System 8000

• Date Initiated by Firm: September 25, 2012
• Date Posted: October 24, 2012
• Recall Status: Terminated on August 21, 2015
• Recall Number: Z-0126-2013
• Recall Event ID: 62315
• 510(K)Number: K915183
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Perfusion System 8000, base 4 pump, 115V safety monitor included; ; 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.
• Code Information: Catalog number: 16400 and serial numbers: 1001-1141, 1143-1274, and 1333.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Rd; Ann Arbor MI 48103-9586
• For Additional Information Contact: 734-741-6173
• Manufacturer Reason for Recall: Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunction
• FDA Determined Cause: Labeling design
• Action: TERUMO sent an URGENT MEDICAL DEVICE letter dated September 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed review the Medical Device Recall notice, assure that all users are aware of the notice and place the addendum in the Operator's Manual before page 1.13. Customers were also instructed to confirm receipt of the Urgent Medical Device letter by faxing, the attached Customer Response Form to 1-800-292-6551. For questions customers were instructed to call 1-800-521-2818.
• Quantity in Commerce: 274
• Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, CALLO PERU, CANADA, CAROLINA PR, CHILE, China, COLOMBIA, Costa Rica, DEKALB, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, Germany, GUAYQUIL ECUADOR, Hong Kong, India, Indonesia, ITALY, Japan, , JARAMA MADRID, Lebanon, LEICESTERSHIRE, MADRID SPAIN, MADRID SPAIN, Malaysia, MEDLEY, Mexico, D.F., MIAMI, MUMBAI 26 INDIA, MUMBAI, New Zealand, Nicaragua, Pakistan, Panama, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, SELANGOR, MALAYSA, SEOUL, KOREA, Singapore, SOUTH AFRICA, South Korea, Sri Lanka, SWITZERLAND, TAIPEI, TAIWAN, Thailand, TUJUNGA, UNITED ARAB EMIRATES (UAE), URUGUAY, Venezuela, Vietnam, VIGNATE ITALY, WOODDALE, and Yemen.
• 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 and Original Applicant = 3M HEALTH CARE, SARNS