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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 Recall
Terumo Advanced PErfusion System 1
see related information
Date Posted August 15, 2013
Recall Status1 Open
Recall Number Z-1978-2013
Recall Event ID 65380
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo® Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns TM or similar equipment.
Code Information Catalog number: 801764
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current users. In the event of a false high pressure alarm condition occurs that displays a "999" pressure reading and results in stopping a pump, this pressure display can be cleared and the pump re-started by disconnecting the pressure transduce
FDA Determined
Cause 2
DESIGN: Software Design
Action Terumo sent an Urgent Medical Device Recall notification letter dated July 26, 2013 to all affected customers. The letter identified the affected product, reason for correction, potential hazards of the recall issue, the correction to be implemented, and customer instructions for replying to the recall notification. Terumo CVS is providing an addendum to be placed in the Operator's Manual at the beginning of Chapter 7, Modules. Questions or concerns are directed to Terumo CVS Customer Service at 1-800-521-2818, Recall Fax 1-877-275-6860. Customer Service hours are Monday to Friday 8am-6pm ET.
Quantity in Commerce 1657
Distribution Worldwide Distribution - US Nationwide in 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, MSMT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and countries of AUSTRALIA, UNITED ARAB EMIRATES (UAE),Hong Kong,Indonesia, Singapore, Taiwan, Thailand,Philippines, CHILE,Malaysia, South Korea, BELGIUM,Japan,Mexico,CANADA
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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