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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description Terumo Advanced Perfusion 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-2009-2012
Classification Class II
Code Info Catalog number: 801763 and serial number: 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 Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The failure of a pump or module to power on, or to lose power after powering on The loss or fluctuation of power or communication in the system network can result in a variety of potential hazards, depending on the system's user-determined configuration. Potential hazards include: " Loss of function of one or multiple modules, including pumps " Loss of one or multiple safety systems " Loss of ability to control the gas blender through the CCM. Terumo CVS is notifying users because the Operators Manual for the Terumo System 1 does not contain sufficient instruction for responding to these issues. As an interim precaution, Terumo CVS is informing users of Terumo System 1 of the risks associated with these failures and providing additional instruction.

Event Detail

Event Id 61763
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 2012-06-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of , 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 and the countries of ARGENTINA, AUSTRALIA, 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.