Enforcement Report - Week of August 15, 2012
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Product Detail
| Product Description | System 1 base 100/120V 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 or similar equipment. |
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| Recall Number | Z-2177-2012 |
| Classification | Class II |
| Code Info | catalog number: 801763 and serial numbers: 0011-0335, 0337-0610,1001-1034, 1037-1049,1100,1103-1106,1109-1450, and 1452. |
| Product Distributed Qty | 992 units |
| Reason For Recall | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS replaced all modules in the affected population. Terumo CVS has subsequently received two additional reports of similar malfunctions. The ensuing investigation concluded that, though highly unlikely, it is possible for the same component to fail in any module. Therefore, Terumo CVS is sending a Safety Advisory (with the same instruction as was provided in AA-2010-007-C) to all Terumo System 1 users and is updating the Operator's Manual with instructions on how to respond to a failure. |
Event Detail
| Event Id | 62444 |
|---|---|
| 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 | 2012-07-26 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. |
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