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U.S. Department of Health and Human Services

Class 2 Device Recall The Terumo Advanced Perfusion System

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 Class 2 Device Recall The Terumo Advanced Perfusion Systemsee related information
Date Initiated by FirmJune 22, 2012
Date PostedJuly 20, 2012
Recall Status1 Terminated 3 on March 06, 2013
Recall NumberZ-2055-2012
Recall Event ID 61242
510(K)NumberK022947 
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
ProductSystem 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.
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/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
734-741-6173
Manufacturer Reason
for Recall		Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application
FDA Determined
Cause 2		Equipment maintenance
ActionTERUMO sent an Urgent Medical Device Recall letter dated June 22, 2012, and an update to the Operator's Manual via Federal Express to inform consignees of the reported malfunction and potential hazards and to raise awareness of the benefits of using a retrograde valve and the importance of backup system availability. Consignees were instructed to review the Medical Device Correction notice, assure that all users are aware of the notice. Place the Addendum at the beginning of the Centrifugal System Section of the Operator's Manual, Confirm receipt of the communication by faxing or emailing a completed Customer Response Form as indicated on the form. For any questions customers should call 1-800-521-2818.
Quantity in Commerce992 devices
DistributionWorldwide Distribution - USA (nationwide) and the countries of Nationwide and worldwide: ARGENTINA, BELGIUM, CANADA, CHILE, 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, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DTQ
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