Enforcement Report - Week of August 29, 2012
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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 |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | 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. | Class II | 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. | 579 units | Z-2230-2012 |
| Serial interface module RS-485 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. | catalog number: 803518 and serial numbers:00007-00038, 00041, and 00043. | Class II | 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. | 34 units | Z-2231-2012 |
| Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500 | catalog number: 802558 and serial numbers:00008-00013, and 00015-00241. | Class II | 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. | 232 units | Z-2232-2012 |
| Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500 | catalog number: 803479 and serial numbers:00009-00122, 00124-00210, 00213-00365, 00367-00458, and 00461-00596. | Class II | 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. | 582 units | Z-2233-2012 |
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