—#108925

Product

System 1 Base, 100/120V. 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.

FDA product code: DTQ — Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K022947
Affected lot / code info: Catalog Number: 801763 and Serial Numbers: 0011-0335,0337-0610,1001- 1034,1037-1049,1100,1103-1106,1109-1445, and 1447-1450.

Why it was recalled

Terumo Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

Root cause (FDA determination)

Process control

Action the firm took

Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 21, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to place the addendum in the Operator's Manual for Terumo System 1, at the beginning of the Central Control Module Section. Additionally, a Customer Response Form was attached for customers to complete and return to the firm. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

Timeline

Recall initiated: 2012-06-21
Posted by FDA: 2012-07-17
Terminated: 2013-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108925. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.