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Heart surgery inherently comes with risks, but the use of the Stockert 3T Heater-Cooler System during the procedure carries an additional and unreasonable risk of infection. Surgeons commonly use the 3T device during heart surgery in order to regulate the patient’s temperature, but this specific system has caused patients across the world to develop life-threatening infections after the procedure. The FDA (Food and Drug Administration) issued a recall in July 2015, but it can take years for patients to exhibit symptoms of infection.
If you or a loved one has been exposed to this medical device, you may be eligible for compensation. Product liability lawsuits have been filed against the 3T manufacturer—LivaNova PLC (formerly Sorin Group Deutchland GmbH)—due to the company’s deceptive measures. The manufacturing company repeatedly misled the FDA, the medical community and the general public on the device’s safety and efficacy.
Our attorneys at Colling Gilbert Wright & Carter in Orlando are experienced in medical malpractice and defective medical device lawsuits and are ready to fight for you. Schedule your FREE consultation today by calling (855) 880-4741.
What is the Stockert 3T Heater-Cooler System?
The 3T system is used during cardiothoracic surgery to regulate the patient’s body temperature. Temperature-controlled water is used to facilitate the heating or cooling through the 3T’s water tank. The water is used for oxygenator heat exchanges, cardioplegia (heart paralysis) and warming/cooling blankets to make sure the patient’s organs and blood maintain a proper temperature during bypass procedures that last 6 hours or less.
Ideally, the Stockert 3T Heater-Cooler System can provide optimal medical care and aid in the outcome of the procedure. Unfortunately, the water tank of the device is the culprit behind the severe infections linked to the defective medical product. While the water doesn’t directly come into contact with the patient, contaminated water can seep into other parts of the 3T device and could also transmit bacteria through the exhaust vent into the surgical environment and the patient.
Nontuberculous mycobacterium (NTM) is the main infection that has been directly linked to the use of the Stockert 3T Heater-Cooler System and can cause serious illness and even death. A European study showed that patients who developed an NTM infection were directly exposed to it during cardiac surgery when the 3T system was used.
In 2014, testing at the manufacturing facility found that the production line and water supply were contaminated with NTM. This facility has sent units worldwide, making it difficult to discern which devices were exposed to the bacterium and which were not.
Additionally, the Stockert 3T system has:
- Shown a high complication and injury rate.
- The potential to fail to perform as intended.
- Required patients to need additional surgeries.
- Lead to severe and irreversible injuries to a significant number of patients.
The manufacturer has since sent letters to patients who may have been exposed to infection. They also released information stating 15 patients initially tested positive for NTM, four of which died—up to 12 patients may have died from infection according to the FDA.
The FDA continues to provide new information about NTM infections linked to the 3T system.
Signs & Symptoms of Nontuberculous Mycobacterium Infection
Patients in the U.S. should be aware of the use of a heater-cooler device during heart surgeries and that the 3T model has specifically been linked to NTM infection. The risk of infection may be higher for patients who have had a prosthetic product or material implanted such as a heart valve, graft or LVAD. A heart transplant can also increase your risk of infection when the 3T is used during surgery.
If you or a loved one has undergone heart surgery in which the Stockert 3T Heater-Cooler System was used, it’s important to speak with your physician whether or not you’re experiencing signs of infection.
Signs of an NTM Infection include:
- Abdominal pain
- Muscle or joint pain
- Night sweats
- Weight loss
- Difficulty breathing
- Ongoing cough or cough with blood
- Pus, heat or redness around the surgical site
How a Defective Medical Device Attorney Can Help
Defective medical device cases require extensive experience and knowledge of the laws surrounding product liability and medical malpractice. Our attorneys in Orlando are well known for our tenacity and can make sure you and your family get the compensation you deserve for the suffering you’ve endured due to the defective and dangerous Stockert 3T Heater-Cooler System.
If you or someone you know has suffered an infection after the 3T system was used during heart surgery, please contact Colling Gilbert Wright & Carter in Orlando immediately at (855) 880-4741. Our attorneys serve clients in Orlando, Florida and nationwide.