Cardiac surgery infection was linked to heater cooler devices in an urgent safety alert sent out by the U.S. Food and Drug Administration (FDA) in October 2015.

The federal drug and medical device oversight agency had received 32 medical device reports from various sources indicating that several open-heart surgery patients had come down with cardiac surgery infection purportedly related to the use of heater cooler devices.

Specifics concerning the brand of device or other information was not offered in the alert, but the FDA made it clear that they intended to keep their fingers on the pulse of the problem.

It wasn’t until eight months later, in June 2016, that the FDA linked several cases of cardiac surgery infection with Mycobacterium chimaera to the Stockert 3T heater cooler device made by LivaNova PLC.

The devices were manufactured in Germany, in a facility that reportedly had been contaminated with mycobacteria. Evidence of the contamination was found during testing of the facility in the fall of 2014. The following summer, the plant was again subject to testing and found to be clear of Mycobacterium chimaera at that time.

While M.chimaera naturally occurs in water and soil and is relatively harmless when encountered day-to-day, it becomes deadly when introduced to very vulnerable heart patients when their chests are open for various bypass and valve repair work.

The cardiac surgery infection grows so slowly that it can take up to four years after the invasive procedure for signs and symptoms to reveal themselves. Due of this fact, several cases of cardiac surgery infection have festered and gone undiagnosed because they were not cognitively connected to the cause by patients and doctors.

What is a Heater Cooler Device?

A heater cooler device is a medical tool used in over 250,000 open-heart surgeries performed in the U.S. annually. This tool consists of a water tank which holds warmer-temperature water next to which the patient’s blood circulates in close proximity (but not in direct contact). This proximal circulation allows the blood to maintain its temperature and, by connection, the organs as well.

The problem with Stockert 3T heater cooler devices manufactured prior to September 2014, according to the FDA, is that their possible contamination with Mycobacterium chimaera could allow the water to become contaminated in the tank and circulate through other parts of the machine. The machine in turn can aerosolize bacteria though exhaust vents and compromise the sterile field of an operating room.

The U.S. Center for Disease Control (CDC) notes a total of 28 cases of cardiac surgery infection to date. Twelve of those 28 allegedly have succumbed to the infection or related complications. The cases linked to the Stockert 3T heater cooler were isolated to the three states of Iowa, Michigan, and Pennsylvania. While no infections have been reported resulting from machines made after September 2014, it is still possible that more cases could reveal themselves.

Former heart surgery patients are encouraged to speak with their physician immediately if they experience extreme flu-like symptoms that include fever, sweating at night, unusual exhaustion, weight loss for no particular reason, or muscle and joint pain.