The Sorin 3T heater-cooler is a popular warming system used in heart surgery, but many patients might not realize until after the fact that they’ve developed an infection because of it.

In recent years, more patients have come forward to allege that the Sorin 3T heater-cooler, as with other devices used during heart surgery, might cause patients to develop serious bacterial infections. These infections require additional medical treatment and can lead to further illness or death.

The Sorin 3T heater-cooler also goes by the name of the Stockert 3T heater- cooler and is manufactured by LivaNova PLC. The device is used to keep the patient’s blood and organs warm during a bypass surgery.

Although the water tanks and the water itself are not designed to come into contact with a patient directly during bypass, contaminated water may enter other locations within the device. When this contaminated liquid is aerosolized, the bacteria can be transmitted to the patient out of the exhaust vent.

The infection is most likely caused by Mycobacterium chimaera, which could have contaminated the Sorin 3T heater-cooler in Germany during the manufacturing process. An analysis completed at that factory identified contamination in 2014.

The manufacturers previously stated that the issue involving contamination had been addressed in the summer of 2015 when the facility went through an additional round of testing. The FDA has stated that as of now, those affected by the issue are patients who went through surgery with a Sorin 3T heater-cooler developed before September 2014.

All surgeries come with a risk of infection and other complications, but those patients who developed an unexplained infection following their heart surgery may have grounds to pursue a lawsuit against the makers of the Sorin 3T heater-cooler.

The first FDA notices about the dangers were released in 2016 and health officials were later notified about how to handle the situation. Although the development of an M. chimaera infection is rare, the side effects can be serious if not caught. The fact that these infections can take months or years to develop means that patients who went through this procedure some time ago may still be at risk to develop an infection. Any patient who had a surgery with this device should be aware of the possible risks.

Currently, infections have been identified in several states, including Michigan, Iowa, and Pennsylvania. These began in 2011 and include cases from at least 28 patients who developed this infection after a surgery using the Sorin 3T heater- cooler.

The FDA states that a minimum of 12 patients have already died as a result of this infection. Some of those surviving patients and the family members of those who suffered fatal injuries have come forward to learn more about their rights for recovery of damages in lawsuits.

Patients should be aware of the side effects of this infection and should get help from their medical professional as soon as possible. The long-term development of this problem can be serious and may include symptoms such as:

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