A device used to control a patient’s body temperature during some types of surgeries, such as open-chest heart procedures, is the subject of lawsuits filed due to the potential transmission of bacteria to patients during its use. The FDA issued a warning about the device, the Sorin Stockert 3T Heater-Cooler System, which is manufactured by LivaNova.
Claims being filed state that LivaNova failed to warn physicians and hospitals that the Stockert 3T caused an increased risk of infections which could cause serious illness or death.
How heater-cooler systems are used.
The Stockert 3T has tanks that control the temperature of water sent through blankets or heat exchangers. These provide warmth or cooling to the patient while heart activity is interrupted during surgeries involving organs in the chest.
According to research, the water in the system became contaminated with infectious bacteria during production of the system in the 3T manufacturing facility. The bacteria spreads by vapors that circulate through an operating room’s ventilation system, and then enter a patient’s open chest cavity.
Why there hasn’t been a Stockert 3T recall.
According to the Centers for Disease Control, the instructions for using the device were recalled by the manufacturer but not the Stockert 3T device. The maker provided information telling users that although water from the 3T is not meant to directly contact patients, it may do so due to aerosolization or fluid leaks, and thereby come into contact with a patient’s surgical site. Heater-cooler systems such as the Stockert 3T remain essential for improving patient outcomes and care during life-saving surgery. It is used in many thousands of bypass surgeries each year.
Symptoms of infection.
Infections caused by the slow-growing mycobacterium chimaera (M. chimaera) microorganism may take months or even years to appear after a patient’s exposure. Fortunately, the type of infection that can result from the Stockert 3T’s contaminated water is not contagious.
Anyone who has had heart surgery during which the Stockert 3T was used should carefully watch for symptoms and complications, including but not limited to:
- Night sweats
- Muscle aches or fatigue
- Weight loss
- Unexplained fever
- Endocarditis
- Surgical site infection
- Abscesses
- Hepatitis
- Renal insufficiency
Call our Stockert 3T Heater-Cooler System Attorneys.
If you or a loved one has suffered from an infection after cardiac surgery that involved the Stockert 3T, contact us for a free consultation to determine if you may have a case. Call us at 904-251-1111 or 800-251-1111 to speak with one of our attorneys.