During heart bypass surgeries, valve replacements, and other types of surgeries that require temporarily stopping the heart, maintaining the patient's body temperature at a specific level is absolutely crucial. The Stockert 3T Heater-Cooler System or the Sorin 3T® Heater-Cooler System, made by LivaNova PLC (formerly Sorin Group Deutschland), uses circulating water to do just that.
Approved for the U.S. market in 2006, the heater-cooler system has since become a staple in operating rooms across the country. However, in 2015, the U.S. Food and Drug Administration (FDA) issued warnings to alert patients and doctors to a link between the Stockert 3T Heater-Cooler System (and similarly designed surgical devices) and dangerous post-operative infections. A year later, the FDA, along with the Centers for Disease Control and Prevention (CDC) issued even sterner warnings to the same effect.
How Does a Heater-Cooler Work?
The Stockert 3T Heater-Cooler and similar devices use a closed system that circulates warm or cool water to regulate the patient's body temperature—as well as the temperature of vital surgical equipment, including bypass machines, heating and cooling blankets, and oxygenators—during major surgeries. The heater-cooler system draws water from three separate tanks and is so sensitive, it allows doctors to adjust the temperature to the tenth decimal point.
Because the water inside the Stockert 3T Heater-Cooler System is in a closed system and doesn't come into direct contact with patients, the link between the machines and dangerous waterborne bacterial infections was long overlooked. However, research now indicates that patients don't necessarily have to touch the water to develop an infection. Instead, health experts say that lethal bacteria, such as Mycobacterium chimaera, grows inside the water tanks, and is aerosolized and expelled into the air via the device's exhaust fan. It then falls into a patient's open chest cavity and lands on surgical equipment.
Patients infected with bacteria from heater-cooler medical devices often “recover” from surgery and go back to their lives, completely unaware of their impending health crisis, as the symptoms associated with the Stockert 3T Heater-Cooler System Mycobacterium chimaera infection can take months, or even years, to develop.
Side effects can include:
- Overwhelming fatigue
- Shortness of breath
- Joint or muscle pain
- Fever that lasts longer than a week
- Night sweats
- Redness or inflammation at the surgical site
Surgical patients who experience these symptoms should consult their physician immediately.
Why Such a Delay in Notification?
The idea of patients developing infections from contaminated heater-cooler devices isn't new; doctors from a German hospital raised the same concerns in a study published in 2002. Additionally, the FDA received reports of infections related to heater-cooler systems since 2010, and federal regulators admit to being aware of the infection risk since 2014, which has led critics to question why there was such a delay to alert the public.
Considering the widespread use of heater-cooler surgical machines like the Stockert 3T Heater-Cooler System, the delay is particularly troubling. Doctors in the U.S. perform more than 250,000 heart bypass operations each year using heater-cooler devices and approximately 60 percent of hospitals who regularly perform heart surgeries use the Stockert 3T. The FDA may have put numerous patients at risk due to its failure to release information regarding the potential for infection.
As of 2016, the FDA had received reports of nearly 80 cases of infections linked to Stockert 3T devices, including 12 fatalities.
Did You Develop a Medical Device-Related Infection?
If you developed a serious infection after having a surgery that used a heater-cooler medical device, you may be facing a number of unforeseen health challenges. Contact McGartland Law today to schedule a free, no-obligation consultation to discuss the potential of filing a medical device lawsuit, and determine if you're eligible to pursue compensation for your injuries. Let our firm use its 30 years of injury case litigation experience to help you fight for the financial award you deserve.