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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 60341
Product Type Devices
Status Ongoing
Recalling Firm Terumo Cardiovascular Systems Corporation
City Ann Arbor
State MI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-22
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries including: Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Central Control Module for System 1: System 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. Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450. Class II Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM resetting itself. If the CCM lost full functionality during bypass, the user would need to operate the pumps using the pumps' redundant controls; safety systems are not compromised. However, the user may experience distraction and/or frustration by the loss of CCM function during a case. 992 units Z-1957-2012
Central Control Module for System 1: 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. Catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313- 0322,1001-1027, 1100-1434, 1436, 1440, and 1441. Class II Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM resetting itself. If the CCM lost full functionality during bypass, the user would need to operate the pumps using the pumps' redundant controls; safety systems are not compromised. However, the user may experience distraction and/or frustration by the loss of CCM function during a case. 648 units Z-1958-2012
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