Patients across the country report they suffered heart surgery injuries after using the Stockert 3T Heater-Cooler System, alleging it led to potentially fatal infections and worsened medical condition.

Also known as the Sorin 3T Heater-Cooler system, affected patients allege their heart surgery injuries were caused by rare non-tuberculosis bacterial infections that have become associated with the cardiac heater-cooler device.

The FDA released a safety communication in October 2016, providing the public with information regarding cardiac heater-cooler infections and heart surgery injuries. The FDA released a list of symptoms associated with cardiac heater-cooler system M. chimera infections, which includes:

• Fatigue
• Fever
• Pain (including abdominal, muscle or joint pain)
• Redness, heat or pus at the surgical site
• Night sweats
• Weight loss
• Nausea
• Vomiting

The FDA recommends patients contact their physician if they experience any of these symptoms after undergoing cardiac surgery that used the Stockert 3T Heater-Cooler System.

Cardiac Heater-Cooler and Potential Heart Surgery Injuries

The Stockert 3T Heater-Cooler is manufactured by LivaNova PLC, which has experienced massive financial success due to the device’s popularity.

The system consists of water tanks that provide temperature-controlled water to other surgical devices. These devices can be used to either raise or lower the patient’s body temperature during cardiac procedures.

The cardiac heater-cooler device is used to control the patient’s body temperature while undergoing surgery, most commonly during cardiopulmonary bypass procedures.

Patients who maintain a stable body temperature during surgery while using the cardiac heater-cooler device are said to have more ideal surgical recoveries. Patients are supposed to experience less bleeding, and they may experience a shorter recover time.

The cardiac heater-cooler is considered very important to use during heart surgeries in particular, because it regulates the temperature of the organs and blood during bypass procedures.

However patients allege they developed dangerous infections due to contamination in the interior of the device. Even though the water does not directly touch the patient, the FDA recently warned “there is potential for contaminated water to enter other parts of the device and aerosolize.”

This means that bacteria can become airborne through the device’s exhaust vent, then come into contact with the patient. The FDA and the Centers for Disease Control and Prevention (CDC) have issued safety warnings regarding the Stockert 3T Heater-Cooler system, stating the devices are linked to potentially fatal bacterial infections.

Cultures taken from patients with these infections contained signs of M. chimera bacterial cells. This is a very rare non-tuberculosis mycobacterium, which can be potentially deadly if not treated promptly. It is important to note that this infection can take months to develop, with more treatment options available if diagnosed early.

Patients who developed heart surgery injuries like deadly infection may be able to take legal action against the manufacturing company. Potential claimants can contact a knowledgeable products liability lawyer to determine eligibility for a cardiac heater-cooler system lawsuit.