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U.S. Department of Health and Human Services

Class 2 Device Recall 100/120V AC, Advanced Perfusion System Platform (APS)

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 Class 2 Recall
100/120V AC, Advanced Perfusion System Platform (APS)
see related information
Date Posted November 27, 2012
Recall Status1 Terminated on August 30, 2013
Recall Number Z-0435-2013
Recall Event ID 63543
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product 100/120V AC, Advanced Perfusion System Platform (APS) 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 all serial numbers
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Terumo Cardiovascular System (TCVS) has received reports of a situation where users experienced a total loss of functionality for some System 1 units. The reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. The result is all pumps stop, with no safety system functionality, and the battery would not be activated. The user would be limi
FDA Determined
Cause 2
DESIGN: Device Design
Action Terumo Cardiovascular Systems sent a Urgent Medical Device Recall Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Terumo CVS is alerting all users of Terumo System 1 of the reports of malfunction. Customers were instructed to: 1. Review this Medical Device Safety Advisory. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/email address indicated on the form. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818, Recall Fax 1-734-741-6149 Customer Service Hours: Monday thru Friday, 8 AM - 6 PM ET.
Quantity in Commerce 1647 units total
Distribution Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTQ and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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