During an inspection last year at Terumo Cardiovascular Systems’ Ann Arbor, Mich., plant, FDA officials found numerous violations to good manufacturing practice and medical device reporting requirements. On March 17, Terumo executive officers signed a consent decree of permanent injunction and under its terms, Terumo will pay almost $35 million in profits from past sales to the federal government.
The Department of Justice (DoJ) will soon file the decree with the U.S. District Court for the Eastern District of Michigan, and under the document terms, Terumo will be prohibited from manufacturing and distributing two of its heart-lung bypass systems and other CV devices to new customers after FDA found that the company did not take corrective and preventive action.
The FDA issued two warning letters to Tokyo, Japan-based Terumo, once in 2004 and once in 2006, about its potential violations to the good manufacturing practice. However, during the FDA inspection that took place between January and March 2010, the agency found violations including nonconforming products, complaints, purchasing, process validation, design controls and adverse event reporting.
“Medical device manufacturers must comply with the FDA’s current Good Manufacturing Practice and Medical Device Reporting requirements, as this action demonstrates,” said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “These requirements protect patients by assuring that medical devices are safe, effective, and high quality.”
The FDA said the decree will restrict Terumo from distributing and manufacturing the following products:
- Terumo Advanced Perfusion System 1;
- Sarns Modular Perfusion System 8000;
- Sarns Centrifugal System;
- HX2 Temperature Management System;
- Sarns TCMII Cooling and Heating System;
- CDI 500 Blood Parameter Monitoring System;
- Sarns Sternal Saw II System and Replacement Blades;
- T-Link Data Management Systems (Software Upgrades);
- Cannulae for cardiopulmonary bypass;
- Cannulae for cardioplegia delivery; and
- Vents, suckers, dilators, connectors and reducers.
In addition, Terumo must cease the distribution of its CDI 101 Hematocrit/Oxygen Saturation Monitoring System, which has not yet been reviewed by the FDA.
Because no devices are under recall, the products will continue their places within the current market and Terumo will continue to provide service, replacement parts and loaner devices to its existing customers.
The company said that the decree does not involve any other Terumo subsidiaries or corporate entities and urged that the products are safe when used in accordance with their instructions for use.
"Terumo CVS is committed to fully addressing all of the FDA's concerns,” said Mark Sutter, president and CEO of the company. “Over the past year, Terumo CVS had already begun implementing a significant quality system initiative that will create systemic, sustainable improvements in its quality aystems.”