The Stockert 3T heater-cooler device has been associated with severe and life-threatening infections. Hundreds of thousands of patients have been exposed to the infection risk, and many required extensive medical treatment to fight infections.
What Is The Stockert 3T?
The Stockert 3T is a device designed to regulate body temperature during open cardiac surgery. The device has water tanks that supply temperature-controlled water to external heat exchangers. These external heat exchangers then transfer the heat from the water into blankets placed over the patient. This allows surgeons to regulate patients’ body temperature during surgery.
How Does The Stockert 3T Heater-Cooler Device Cause Infections?
The water in the Stockert 3T runs in a closed circuit, meaning it doesn’t come into direct contact with patients. However, the water does enter into other parts of the device and bacteria can be transmitted through the air cycling through the device’s exhaust vent. This means the Stockert 3T can express water contaminated by bacteria into the operating room and into patients’ open surgical wounds.
FDA Review of The Stockert 3T Device
In 2015, the U.S. Food and Drug Administration (FDA) sent a warning letter to physicians and patients because the agency determined use of the Stockert 3T was associated with surgical site infections. Specifically, the devices have been associated with Nontuberculous Mycobacteria (NTM) infections, Mycobacterium Chimaera infections, and others.
Since the initial warning letter, the FDA has continued to investigate the association between the Stockert 3T and infections, and has continued to warn doctors and patients of the infection risk.
Medical Device Manufacturer Recalled The Stockert 3T
Shortly before the FDA released its warning letter regarding the Stockert 3T device and its infection risk, the manufacturer of the device, LivaNova PLC, recalled some of its devices due to a contamination risk. Unfortunately, this recall came far too late for millions of patients who had already undergone surgery with the device.
Infections Caused by The Stockert Device
Mycobacteria refers to a large family of germs that can cause a variety of severe and life-threatening infections. Two types of mycobacteria have been most commonly associated with the Stockert 3T device: nontuberculous mycobacteria and mycobacterium chimaera. Treating any type of mycobacteria is incredibly difficult. Patients require extensive antibiotic therapy and might require additional surgeries.
Mycobacteria can lay dormant inside a patient’s body for months or even years before the patient begins to experience symptoms. Some of the most common symptoms associated with these infections include:
- Redness, heat, or pus at the surgical site
- Abdominal pain
- Muscle pain
- Joint pain
- Night sweats
- Weight loss
- Nausea and vomiting
Unfortunately, patients who experience mycobacterial infections from the Stockert 3T can suffer additional complications. The most common complications reported by patients include:
- Endocarditis – Mycobacteria can cause infections in the heart’s inner lining, leading to inflammation and other painful side effects.
- Surgical site infection – Infections at the surgical site can be severe and involve infected tissues and organs near the surgical site.
- Bacteremia – Bacteremia occurs when bacteria is present in the bloodstream. This can cause the bacteria to spread to other parts of the body.
- Hepatitis – Bacteria can cause inflammation in the liver called Hepatitis, which can cause serious complications like liver cancer.
- Splenomegaly – Splenomegaly is the enlargement of the spleen. While some patients do not experience symptoms of this condition, others will suffer severe pain, bleeding, fatigue, and other effects.
- Osteomyelitis – A rare but serious condition, osteomyelitis is an infection of the bone, which could require amputation of the infected limb.
Stockert 3T Infection Attorneys
All surgeries come with risks, but patients who were subjected to the Stockert 3T device during their procedures were not warned of the device’s increased risk of infections and the serious complications that could occur. If you or someone you love suffered an infection after open-heart surgery, you may be able to obtain compensation. The experienced Stockert 3T infection law firm of Blizzard & Nabers LLP can analyze your situation and help you understand your legal rights. Call us today to schedule a free consultation.