FDA: Michigan Heart-Lung Bypass Machine Manufacturer Enters Into Consent Decree
SILVER SPRING, Md., March 22, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that Terumo Cardiovascular Systems Corporation (TCVS) of Ann Arbor, Mich., and two of its officers, Mark A. Sutter, president and chief executive officer, and Mark Lincoln, vice president of Quality Assurance and Operations, have signed a consent decree of permanent injunction.
The consent decree, to be filed in the U.S. District Court for the Eastern District of Michigan by the Department of Justice, Office of Consumer Litigation, and the United States Attorney's Office, prohibits the company from manufacturing and distributing two heart-lung bypass systems and other cardiovascular devices to new customers.
The consent decree also restricts sale of these systems to existing customers until TCVS complies with the FDA's current Good Manufacturing Practice (cGMP) and Medical Device Reporting (MDR) requirements.
TCVS also agreed to pay the federal government $35 million in disgorgement of profits derived from past sales and additional disgorgement amounts should it fail to comply with the provisions of the consent decree in an effective and timely manner.
"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."
During an inspection from January through March 2010, FDA investigators observed numerous cGMP and MDR violations at the company's Ann Arbor manufacturing facility. The violations included deficiencies in processes for corrective and preventiv