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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description 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.
Recall Number Z-1957-2012
Classification Class II
Code Info Catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
Product Distributed Qty 992 units
Reason For Recall 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.

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.