Numerous patients across the country are reporting cardiac bypass surgery infection after undergoing cardiac surgery using a Stockert 3T Heater Cooler System.

These cardiac bypass surgery infection injury reports indicate the devices directly contributed to potentially deadly bacterial infections which can manifest years after the procedure.

The Stockert 3T Heater Cooler System has been linked to rare non-tuberculous bacterial infections involving Mycobacterium chimaera that has reportedly caused serious illness or even death in cardiac bypass surgery infection cases.

This bacterium is found in water and soil which normally does not produce serious illness in humans until it was reported in conjunction with Stockert 3T Heater Cooler System.

It is important to note that in many of these cases, the cardiac bypass surgery infection did not develop immediately after the procedure. In fact, some patients report getting sick up to two or three years later, which has made it difficult for investigators to determine the point of origin.

In 49 cases of cardiac bypass surgery infection, at least 24 of them resulted in death. Investigators noted that in each of these cases, patients had undergone cardiac bypass surgery while utilizing a heater cooler device.

Overview of Cardiac Bypass Surgery Infection

Reports of cardiac bypass surgery infection in conjunction with use of the 3T Heater Cooler System were submitted as early as 2011, with patients from Iowa, Michigan and Pennsylvania among the reports. According the CDC, there have been a total 28 confirmed cardiac bypass surgery infection cases.

The FDA reports that at least 12 patients have died likely as a result of the bacterial infections. Due to the fact that these infections can develop long after surgery, the CDC is encouraging patients who recently underwent heart surgery to seek medical attention if they experience the following symptoms:

• Night sweats
• Muscle aches
• Weight loss
• Fatigue
• Unexplained fever

Heater cooler devices are used for temperature regulation. These devices are used to maintain the temperature of the patient’s blood and are typically connected to other equipment like heating and cooling blankets.

The Stockert 3T Heater Cooler System is one of the most widely used of these medical devices and is used in the surgeries of numerous patients. The danger of bacterial infections stems from the device’s exhaust vent, which reportedly allows for contaminated water to be released into the air of the operating room and come into contact with patients.

The Stockert 3T Heater Cooler System devices were manufactured in an allegedly contaminated location in Germany. Testing conducted on the manufacturing plant in September 2014 concluded that M. chimaera was present.

Even though the issue at the factory was reportedly resolved in July 2015, the FDA states that Stockert 3T Heater Cooler devices manufactured before September 2014 could be at risk for bacterial contamination.

The FDA issued its first safety warning regarding potential cardiac bypass surgery infection in October 2015, with the agency stating it had received 32 Medical Device Reports regarding patients who allegedly developed these injuries.

The FDA did not specifically state the Stockert Heater Cooler devices were linked to M. chimaera bacterial infections until an updated warning was released in June 2016.