Cardiac heater-cooling systems, used to keep patients warm during heart surgery, are under fire as the bacteria M. chimaera has been found in patients as an alleged result of the heater-cooler system use.

Doctors who perform hundreds of thousands of cardiac procedures in hospitals around the country utilize such systems.

Specifically, the LivaNova PLC Stockert 3T heater-cooler machine has been pointed out to possibly allow patients to contract a bacteria known as M. chimaera.

M. chimaera is a nontuberculous mycobacterium (NTM) that is classified as a slow-grower. M. chimaera can cause severe illness or death. It breeds in water as well as soil and sickens healthy patients.

Recently, the US Food and Drug Administration updated an earlier safety communication that stated the risks associated with the Stockert 3T Heater-Cooler System.

According to the FDA, heater-cooler devices are commonly used in cardiothoracic surgeries as well as other medical and surgical procedures to warm or cool a patient to improve patient outcomes.

The devices have water tanks that provide water that is temperature-controlled to external heat-exchangers or warming/cooling blankets. The water does not come into direct contact with the patient, but there is a possibility that contaminated water can enter other parts of the device and become airborne.

This action has the potential to transmit bacteria, like the M. chimaera strain, through the air and through the device’s exhaust vent into the environment and to the patient.

The FDA also reports that in April 2016, a published European study showed a link between M. chimaera samples from European patients, samples from heater-cooler devices that were used during those patients’ surgeries and environmental samples from the devices’ manufacturing plant.

This study showed a direct link between the M. chimaera that infected those patients during open-heart surgery and the M. chimaera found in the heater-cooler devices.

It has been reported that more than 45 infections and at least nine deaths have been linked to this heater-cooler device.

In speaking of the heater-cooler devices, Dr. Michael Bell with the Centers for Disease Control and Prevention said, “A wet machine with a big fan can result in these organisms. We need a better way of managing machines like this or a better design that doesn’t have that problem.”

Symptoms of an M. chimaera infection include fever, fatigue, muscle aches, night sweats and weight loss. Currently, a patient cannot get a test to discover if he or she has M. chimaera, but lab cultures can be taken to discover it.

The problem with heater-cooler devices and M. chimaera has become so bad that the devices list at number five on the ECRI Institute’s “Top 10 Health Technology Hazards for 2017” list.

If you or someone you love has been adversely affected by a heater-cooler device or has contracted M. chimaera as a result of heater-cooler device use during a procedure, you may be entitled to legal compensation.