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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 14, 2013
Recall Status1 Open
Recall Number Z-1974-2013
Recall Event ID 65381
Premarket Notification
510(K) Number
K022947 
Product Classification Console, Heart-Lung Machine, Cardiopulmonary Bypass - Product Code DTQ
Product Terumo® Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC 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 or Part Number: 801764 Description: 220/240V AC, Advanced Perfusion System 1
Recalling Firm/
Manufacturer
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor, Michigan 48103-9586
Manufacturer Reason
for Recall
Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump 'Service Pump' message may occur due to user induced motor movement. In this instance, the APS1 will identify the movement (as it is designed) and display a Service Pump message error. The user might interpret this as a pump which requires service rather than a message displayed d
FDA Determined
Cause 2
DESIGN: Device Design
Action Terumo Cardiovascular Systems (TCVS) notified their consignees of the Urgent Medical Device Recall letter dated 7/26/13 and was mailed 7/29/13. The notification provided reason for the device correction, affected product, how the device will be corrected, and the potential health hazard associated with a user's inaccurate interpretation of the service pump error message. Instructions for consignee responses to the recall notice communication may be faxed to 734-741-6149 or emailed to the address on the return form. If you have any questions or concerns, call Terumo Cardiovascular Systems (TCVS) Customer Service at 1-800-521-2818 M-F, 8am-6pm ET. Terumo Cardiovascular Systems (TCVS) will provide an addendum to the APS1 Manual to their consignees. The addendum will be placed at the beginning of Chapter 6, Centrifugal Control Unit.
Quantity in Commerce 1657
Distribution Worlwide Distribution - US Nationwide: AL,AR,AZ, CA, CO, CT, DC, DE, FL,GA, HI, IA, ID, IL, IN, KY, LA, MA , MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of: AUSTRALIA,UNITED ARAB EMIRATES (UAE),Hong Kong, onesia,Singapore,Taiwan,Thailand, Philippines,CHILE, Malaysia,USA,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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