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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 62322
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 2012-09-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, Singapore, Jordan, Japan, Vietnam, Germany, Russia, Saudi Arabia, BELGIUM, Mexico, and CANADA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Terumo Advanced Perfusion System 1 Flow Module 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. Catalog number: 802018 and serial numbers: 00122, 00337, 00340, 00343-00389, 00391-00395, 00397-00410, 00437, 00438, and 00488. Class II Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on the Central Control Monitor or the Centrifugal Control Unit. The tricolor LED on the flow module was not illuminated. Terumo CVS' investigation found that the malfunction was caused by an improper component on a circuit board used in a population of flow modules for Terumo System 1. 72 units Z-2449-2012