—#108193

Product

System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in 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 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.

Root cause (FDA determination)

Device Design

Action the firm took

TERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to review the Medical Device Recall Notice, assure that all users are aware of the notice. Consignees should place the Addendum at the beginning of the System Base Section (page 3-1) of the Operator's manual, confirm receipt of this communication by faxing the attached Customer Response Form to the fax number indicated on the form. All System 1 product is on quality hold. Terumo CVS will release product including batteries as needed only in the event that customers require service. All affected System 1 customers will receive a safety notification and an addendum to the Operator's Manual. There will be a field correction but no product returned for this recall. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV. Internationally to: Republic, Egypt, Germany, Guatamala, Honduras, Hong Kong, India, Indonesia, 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: 2012-06-22
Posted by FDA: 2012-07-09
Terminated: 2013-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.