Terumo Cardiovascular Systems, an Ann Arbor-based subsidiary of Terumo Corporation of Tokyo, Japan, announced it has agreed to the terms of a consent decree with the U.S. Food & Drug Administration regarding quality system improvements at the company’s Ann Arbor plant.
The agreement will be subject to the approval of the United States District Court for the Eastern District of Michigan.
The consent decree addresses observations raised by FDA inspectors during audits of quality system processes at the company’s Ann Arbor plant.
The consent decree 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.
Under the agreement, Terumo CVS will create and execute a work plan to resolve the observations.
Other Terumo CVS products are available without restriction, including: oxygenators, perfusion circuits that don’t contain cannulae, and all other products produced at the company’s other manufacturing facilities in Elkton, Md. and Ashland, Mass.; and products distributed by Terumo CVS that are manufactured by other suppliers.
The consent decree does not involve any other Terumo subsidiary or corporate entity.
The consent decree does not require that the company remove, recall or perform corrective actions on any products in use at customer facilities.
“Terumo CVS is committed to fully addressing all of the FDA’s concerns,” said Mark Sutter, president and CEO of Terumo CVS. “Over the past year, Terumo CVS had already begun implementing a significant quality system initiative that will create systemic, sustainable improvements in its Quality Systems. Terumo CVS has always been, and will remain, committed to those in the cardiac surgery community who use our products. Our ultimate goal during the consent decree is minimizing the inconvenience or disruption to our customers.”
Said Steven Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health: “Medical device manufacturers must comply with the FDA’s current Good Manufacturing Practice and Medical Device Reporting requirements, as this action demonstrates. 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 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.