FDA warns of potential issue with the Stӧckert 3T Heater-Cooler System

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Some patients who underwent cardiothoracic surgery that involved the use of the Stӧckert 3T Heater-Cooler System have been infected with M. chimaera, according to an FDA safety warning issued on June 1.

The FDA’s circulatory system devices panel plans on reviewing available data and seeking information on heater-cooler device contaminations during a meeting on June 2 and 3.

As of now, efforts are underway to determine if the infections in the U.S. are related to infections of European patients who were previously identified at the 3T manufacturer’s production and servicing facility in Germany.

Sorin Group Deustchland GmbH, which manufactures the 3T heater-cooler system, found M. chimaera contamination on the production line and water supply during testing in August 2014. The company added cleaning and disinfection procedures in September 2014, according to the FDA, which added that samples taken at the same facility in June 2015 did not show M. chimaera on the production line.

“M. chimaera is a type of nontuberculous mycobacterium (NTM) that may cause serious illness or death,” the FDA said. “FDA believes these NTM infections associated with the 3T are rare. However, they are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”

The FDA said that facilities that purchased and used the 3T heater-cooler system before September 2014 may have had units that were contaminated with M. chimaera. Those facilities should tell healthcare providers about the potential issue. Reports suggest that patients who underwent heart valve, graft or LVAD surgery or heart transplants may have a greater risk of being infected with M. chimaera.

Facilities that purchased the 3T heater-cooler system after September 2014 should follow recommendations that the FDA provided in safety communication alert in October 2014.

Heater-cooler devices are commonly used during cardiothoracic surgeries. The FDA said the 3T heater-cooler system is intended to provide temperature-controlled water to oxygenator heat exchangers, cardioplegia heat exchangers and/or warming/cooling blankets to warm or cool patients during cardiopulmonary bypass procedures that last six hours or less.