—#110203

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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K915183
Affected lot / code info: Catalog number: 16400 and serial numbers: 1001-1141, 1143-1274, and 1333.

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-09-25
Posted by FDA: 2012-10-24
Terminated: 2015-08-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.