In September  2014, inspectors found evidence of bacterial contamination at the facility where the Stockert 3T Heater-Cooler Device was manufactured.

The Stockert 3T Heater-Cooler Device and other like-functioning equipment are used in cardiac bypass and other open-heart surgeries.

Between September 2014, when Mycobacterium chimaera was found at the Germany-based manufacturing location, and July 2015, when the site was repeat tested and found clear of contamination, there were no linked cases of infection in heart patients.

The problem resides with the fact that exposure to this bacterium can take a long time to turn into a full-blown infection – sometimes years.

What Does a 3T Heater-Cooler Device Do?

A 3T Heater-Cooler Device works to keep a heart patient’s blood and vital organs at the right homeostatic internal body temperature during a very invasive surgical procedure.

It contains a tank that is filled with water heated to a very specific temperature.  The water in this tank does not actually encounter any part of the patient. But if the interior of the tank becomes contaminated, as was believed to be case with the Stockert model, bacteria can theoretically pass through the machine parts and become an infecting mist in the operating room.

According to Texasheart.org, there are up to 500,000 cardiac bypass surgeries performed in the U.S. each year alone. They also estimate more than 2,300 people undergoing heart transplant surgery in the U.S. annually.

These figures translate into a lot of potential exposure to injurious or even potentially deadly bacterium like Mycobacterium chimaera that could show up in patients at a much later date.

What Should Former Heart Surgery Patients Know?

The Centers for Disease Control and Prevention (CDC) has issued a warning to people that have undergone any open-heart surgery.

If you have experienced symptoms that are strongly associated with infection, they urge you to get medical advice and care as soon as possible.  These symptoms are unexplained fever, weight loss, night sweats, chronic fatigue and aching muscles.

The CDC estimates that roughly 60% of cardiac bypass surgeries use the 3T heater-cooler device thathas been associated with Mycobacterium chimaera contamination. Seriously injurious events follow infection with this bacterium, and in rare cases, death follows.

The Food and Drug Administration’s (FDA) Review of the 3T Heater-Cooler Device

These devices have both increased survival rates for these highly risky surgeries and put patients at risk through exposure.  Because of this, the FDA continues to collaborate with manufacturers on elements of design that could reduce risk as well as with scientists and medical professionals.

Some unit elements that have been looked at are the exhaust fans which can contribute to desterilization of the surgical field, and air and water filters that may be inadequate.

The FDA released its first warning in October 2015 regarding the 3T heater-cooler device and updated this warning in October 2016 to inform health professionals.

The FDA wished to provided clear guidelines as to how to reduce the chance of infection with the second communication.  Infections likely resulting from the use of a 3T heater-cooler device have not been reported any earlier than 2011.