Editor's Note: The U.S. District Court for the Eastern District of Michigan signed and entered the consent decree on March 29, 2011. The decree is now effective.
FDA NEWS RELEASE
For Immediate Release: March 22, 2011
Media Inquiries: Karen Riley, 301-796-4674; email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA: Michigan heart-lung bypass machine manufacturer enters into consent decree
Terumo Cardiovascular Systems Corp. agrees to give up $35 million in profits
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 preventive action, nonconforming product, complaints, purchasing, process validation, design controls, and adverse event reporting.
The FDA has twice warned TCVS about its cGMP problems, issuing warning letters to the company in 2004 and in 2006.
Heart-lung bypass systems, also called perfusion systems, keep blood circulating and oxygenated by temporarily taking over the function of the heart and lungs during cardiac or thoracic surgery.
The consent decree restricts the company 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
• Vents, suckers, dilators, connectors, and reducers.
The company must also stop distributing the CDI 101 Hematocrit/Oxygen Saturation Monitoring System, which has yet to be reviewed by the FDA.
Because of concerns about possible shortages, the consent decree does not require TCVS to remove the listed products from the market. The company will be allowed to continue to provide service, replacement parts, and loaner devices to existing customers that submit documentation of medical need.
TCVS will be sending its customers a notification guide, which will include instructions for completing and returning a certificate of medical necessity. Its customers can contact the company by phone at 1-800-521-2818 or by email at firstname.lastname@example.org. TCVS plans to establish a customer website: www.terumo-cvs.com/consentdecree.
The decree becomes effective when it has been filed with and entered by the court.
For more information
Aug. 31, 2004 FDA Warning Letter to Terumo Cardiovascular Systems
Aug. 31, 2006 FDA Warning Letter to Terumo Cardiovascular Systems