ANN ARBOR – Terumo Cardiovascular Systems Tuesday announced it has agreed pay $35 million in fines and to reduce manufacturing and sales of several of its medical devices after the U.S. Food and Drug Administration discovered numerous violations at the company’s Scio Township headquarters.

The Japanese owned company signed a consent decree agreeing that it will not manufacture or sell two heart-lung bypass systems and several other medical devices to new customers until it makes improvements to its manufacturing and reporting systems as required by the FDA.

Terumo CVS ? which has 435 employees at its Scio Township operation, up from 367 a year ago ? can continue to sell the products to existing customers, a spokeswoman told AnnArbor.Com.

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, Maryland and Ashland, Massachusetts; 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.

?Terumo CVS is committed to fully addressing all of the FDA?s concerns. 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,? said Mark Sutter, President & Chief Executive Officer, Terumo CVS. ?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.?

According to FDA documents provided to AnnArbor.com, four FDA investigators who inspected the Scio Township facility in early 2010 concluded that Terumo CVS had ?not implemented an adequate and effective quality system at all levels of your organization.?

The issues cited by the FDA investigators included an incident in which a patient died some time after Terumo CVS? ?soft flow arterial cannula? was removed from the patient with a blood ?clot found entangled in the diffuser tip of the cannula.?

?Your firm did not document the attempts to retrieve the product from the hospital, or document the reason why no products were returned for investigation,? the Detroit-based FDA investigators concluded in their report. ?The investigation conducted by your firm did not include any attempts to try and recreate the problem on the remaining inventory in stock. Only a visual inspection of the remaining stock was conducted.?

The investigators added: ?The investigation did not determine if your firm?s product caused or contributed to the patient?s death.?

In response to the FDA’s assertions, Terumo and the hospital that treated the patient jointly investigated the incident and found that the cannula had nothing to do with the patient’s death, said Barbara Schmid, Terumo CVS’ director of corporate communications.

“We are 100 percent convinced and so is the hospital that there is no relation between that cannula and that patient?s death,” she said. “Cardiac surgery is a very, very common procedure and our products are used many, many times every day.”

The FDA, she said, only “felt that we did not do adequate investigation into the incident. That needs to be clear.”

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