Enforcement Report - Week of August 29, 2012
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Product Detail
| Product Description | Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure. |
|---|---|
| Recall Number | Z-2230-2012 |
| Classification | Class II |
| Code Info | catalog number: 802113 and serial numbers: 00007-00036, 00038-00045, 00047-00064, 00066-00077, 00080-00121, 00123-00214,00216-00283, 00285-00363, 00366-00498, 00500-00548, and 00550-00597. |
| Product Distributed Qty | 579 units |
| Reason For Recall | Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the module. Terumo CVS's investigation has determined that the the malfunctions are caused by a circuit board that failed. There have been no reports of patient injury as a result of this issue. |
Event Detail
| Event Id | 62684 |
|---|---|
| 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 - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam |
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