A Sorin Stockert 3T Heater-Cooler System® is a medical device designed to regulate the body temperature of a patient during a cardioplegic surgery — a procedure that stops the heart and flow of blood. The Sorin Stockert 3T Heater-Cooler System, manufactured by LivaNova, uses three circuits to simultaneously keep patients warm while also using cold water for cardioplegia—the intentional and temporary cessation of cardiac activity during surgery. The device is primarily used for invasive surgeries involving the heart, lungs, esophagus, and other chest organs. These devices have water tanks that provide temperature-controlled water to external heat exchangers or warming or cooling blankets through closed circuits. Though the water never comes into contact with the patient, the devices have fans and exhaust vents. Contaminated water from inside the device can aerosolize as it travels through the closed circuits. That contaminated air can then be pushed into the operating room through the exhaust vents where it can contaminate the patient undergoing cardiothoracic surgery. The Centers for Disease Control and Prevention (CDC) estimates that more than 250,000 heart bypass procedures using HCUs are performed in the U.S. each year. HCUs are used during these procedures because they keep the patient’s circulating blood at a safe temperature while the beating of the heart is temporarily stopped.
ISSUES WITH THE SORIN STOCKERT 3T
The Food & Drug Administration (FDA) issued a warning letter in 2015 after it was discovered that patients of open-heart surgery may have been exposed to the dangerous Mycobacterium Chimaera bacteria. Laboratory tests reportedly found this bacteria in certain Sorin Stockert 3T Heater-Cooler Systems, according to FDA. It’s believed that the bacteria may have contaminated the water tank of these devices during manufacture in Germany. This exposure has reportedly led to severe infections and even death among some patients who had an open-heart surgery performed using the Sorin Stockert 3T Heater-Cooler System. Worse yet, the bacteria can stay dormant and it can take months or even years for symptoms to develop.
MYCOBACTERIUM CHIMAERA INFECTION SYMPTOMS
If you have had open-heart surgery in recent years, you should be on the lookout for certain symptoms of an infection associated with exposure to Mycobaterium Chimaera. According to the FDA these symptoms may include:
- REDNESS, HEAT, OR PUS AT THE SURGICAL SITE
- MUSCLE PAIN
- JOINT PAIN
- NIGHT SWEATS
- WEIGHT LOSS
- ABDOMINAL PAIN
A Mycobaterium Chimaera infection can potentially be fatal, so seek medical care immediately if you experience any of the above symptoms. Other infection-related complications that can occur up to years after surgery include:
- SURGICAL SITE INFECTION
- ENDOCARDITIS (INFLAMMATION OF THE UNNER LINING OF THE HEART)
- BACTEREMIA (BACTERIA IN THE BLOOD)
- OSTEOMYELITIS (INFLAMMATION IN THE BONE)
DO YOU NEED HELP WITH A POTENTIAL SORIN STOCKET 3T SYSTEM CLAIM?
If you or a loved one have been diagnosed with Mycobaterium Chimaera due to the Sorin Stockert 3T Heater-Cooler System, we encourage you to consult with our team as soon as possible. With our extensive knowledge and expertise, you can rest assured that should you choose to work with us, you will have legal representation that you can trust. All initial consultations are free, and we don’t charge any up-front fees for representation. We handle all fees on a contingency basis, meaning that unless we’re successful, you don’t have to pay us. Please contact Fulmer Sill at (405)510.0077 for a free consultation.