—#110355

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 Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctions of the Terumo Advanced Perfusion System 1 that could result in the inability to use the pump and would then require replacement with back-up equipment. Description of malfunctions: " Unplanned pump stop or pause " Changes in pump speed If it is necessary to replace a roller pump during cardiopu

Root cause (FDA determination)

Device Design

Action the firm took

Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Customer Response Form to the firm via fax at 1-800-292-6551. Contact the firm at 1-800-521-2818 for questions regarding this recall.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.

Timeline

Recall initiated: 2012-06-25
Posted by FDA: 2012-07-09
Terminated: 2013-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110355. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.