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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo Advanced Perfusion System 1

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  Class 2 Device Recall Terumo Advanced Perfusion System 1 see related information
Date Initiated by Firm June 25, 2012
Date Posted July 09, 2012
Recall Status1 Terminated 3 on September 18, 2015
Recall Number Z-1969-2012
Recall Event ID 62367
510(K)Number K022947  
Product Classification Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
Product System 1 Base 220/240V

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: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and1441.
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) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. If it is
FDA Determined
Cause 2		 Equipment maintenance
Action The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" notification dated June 25, 2012 and an update to the Operator's Manual for the Terumo Advanced Perfusion System 1 via Federal Express to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review this Medical Device Recall notice; assure that all users are aware of this notice; place the addendum at the beginning of the Roller Pumps Section (page 5.1) of the Operator's Manual, and complete and return the attached Customer Response Form to the fax number/email address indicated on the form. Note: Terumo is continuing its investigation into the root cause of the malfunctions, and may initiate further action pending results of the investigation. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours: Monday-Friday, 8 AM - 6 PM (ET).
Quantity in Commerce 648 units
Distribution Worldwide distribution: USA (nationwide) and countries including: Germany, 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.
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.
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