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U.S. Department of Health and Human Services

Class 2 Device Recall The Terumo Advanced Perfusion System 1

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  Class 2 Device Recall The Terumo Advanced Perfusion System 1 see related information
Date Initiated by Firm June 22, 2012
Date Posted July 09, 2012
Recall Status1 Terminated 3 on November 08, 2013
Recall Number Z-1965-2012
Recall Event ID 61480
510(K)Number K022947  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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.
Code Information Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Tracy Bellanca
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce approx. 993 units
Distribution 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,
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 = TERUMO CARDIOVASCULAR SYSTEMS CORP.