Sorin LivaNova 3T Heater-Cooler System: Bacteria Infection Lawsuits
Commonly asked questions about Sorin LivaNova 3T heater-cooler systems:
- What are Sorin LivaNova 3T Heater-cooler Systems?
- Is LivaNova 3T Heater-Cooler Device Linked To Bacterial Infection?
- Common Symptoms of Nontuberculous Mycobacterium Infections
- What are Types of Heater-Cooler Systems?
- Surgeries That May Include Use Of LivaNova 3T Heater-Coolers
- Can I File A Sorin LivaNova 3T Heater-Cooler System Lawsuit?
- How Do I Start A Sorin LivaNova 3T Heater-Cooler Claim?
What are Sorin LivaNova 3T Heater-cooler Systems?
Sorin, which recently merged with Cyberonics, manufactures the LivaNova 3T heater-cooler system — a device used to maintain patients’ blood and organs at a specific temperature.
The heater-cooler system provides three circuits for heating and cooling, and separate settings for warm cardioplegia, cold cardioplegia and patient temperature. The system essentially eliminates the need for ice and water supply in operating rooms.
The LivaNova 3T device is used in roughly 60 percent — approximately 150,000 total — of heart bypass procedures across the United States, according to the CDC.
The device was introduced to the market via 510k pre-market notification in 2006. Several years later, reports surfaced of mycobacteria infections in patients who utilized the cardiopulmonary surgical equipment.
In some cases, the contamination can be traced to LivaNova’s production facility in Germany.
There are at least 15 federal lawsuits alleging injuries caused by the Sorin LivaNova 3T Heater-Cooler System, according to Harris Martin. Approximately 10 of those cases are reportedly pending in the U.S. District Court for the District of South Carolina. These cases have been assigned to Judge Bruce H. Hendricks in Greenville, S.C.
Plaintiffs who have filed lawsuits reportedly content the Sorin heater-cooler device causes bacteria to become aerosolized into an operating room, resulting in pathogen exposures that significantly exceed naturally occurring background levels.
Is LivaNova 3T Heater-Cooler Device Linked To Bacterial Infection?
The U.S. Centers for Disease Control & Prevention and the U.S. Food and Drug Administration (FDA) are currently investigating reports that the Sorin 3T Heater-Cooler System has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM).
The CDC issued a release October 2016 warning healthcare providers and patients about the potential risk of infection from similar devices used during open heart (open-chest) surgery.
“This advice follows new information indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections,” the CDC said in a released statement.
The CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.
Many hospitals are sending warning letters to patients who may have been exposed, most of whom had surgery since January 1, 2012. Hospitals in Pennsylvania, Iowa, and Michigan have confirmed 28 cases of infection, some diagnosed almost four years after surgery.
Common Symptoms of Nontuberculous Mycobacterium Infections
According to the CDC, patients exposed to contaminated water in the Sorin 3T Heater-Cooler System may experience the following side effects:
- Unexplained fever
- Sudden weight loss
- Night sweats
- Muscle aches
- Blood in the sputum (phlegm)
“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion. “Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”
The CDC’s Morbidity and Mortality Weekly Report, published in October 2016, details recently completed laboratory tests by CDC and National Jewish Health that show bacteria from the 3T heater-cooler devices match bacteria found in patients in several states. These results build on previous evidence from Europe that suggests the bacteria contaminated these devices during manufacturing in Germany, the CDC said in a released statement.
What are Types of Heater-Cooler Systems?
The Sorin Stockert LivaNova 3T, approved by the FDA in 2006, was the first heater-cooler device to market and remains the most popular heater-cooler device on the market. Other heater-cooler systems include:
Surgeries That May Include Use Of LivaNova 3T Heater-Coolers
The following types of surgeries may require or include the use of the Sorin LivaNova 3T Heater-Cooler System:
- Heart valve replacement
- Heart transplant
- Lung transplant
- Coronary artery bypass graft (CABG)
- Extracorporeal membrane oxygenation (ECMO)
- Left ventricular assist device (LVAD) implant
- Aortic anomaly surgery
- Pulmonary artery banding
- Lung resection
LivaNova currently operates as three business units: cardiac surgery, cardiac rhythm management and neuromodulation, with operating headquarters in Mirandola (Italy), Clamart (France) and Houston (U.S.) respectively.
The company has a presence in more than 100 countries around the world with approximately 4,500 employees.
About Sorin Group
Sorin — medical device company — develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders.
With approximately 3,900 employees worldwide, Sorin focuses on two major therapeutic areas: cardiac surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and cardiac rhythm management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment).
More than one million patients are treated with Sorin devices annually in more than 100 countries.
Can I File A Sorin LivaNova 3T Heater-Cooler System Lawsuit?
Our Sorin LivaNova 3T Heater-Cooler System lawyers can help if you or someone you care about contracted a severe — or possibly fatal — infection as a result of being exposed to bacteria from a contaminated heater-cooler device. Our top Sorin LivaNova 3T Heater-Cooler System lawyers are handling individual litigation nationwide and currently accepting new heater-cooler cases in all 50 states.
The criteria for filing a heater-cooler infection lawsuit include the following:
- Had open heart surgery less than six years ago and
- Had one of more of the following symptoms at least eight weeks after surgery that could not be explained due to other causes:
- Night sweats
- Muscle aches
- Weight loss
- Fever, and
- Symptoms were severe and persistent enough for the client to seek medical treatment or
- Received a warning letter about potential risk from the hospital where they had surgery or
- Diagnosed with a Mycobacterium Chimaera/nontuberculous mycrobacterium (NTM) infection
Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed by a Sorin LivaNova 3T Heater-Cooler System.
Our No-Fee Promise On Sorin LivaNova 3T Heater-Cooler Cases
You can afford to have our great team of Sorin LivaNova 3T Heater-Cooler System lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a heater-cooler settlement
- Phone calls are always free
How Do I Start A Sorin LivaNova 3T Heater-Cooler Claim?
Our Sorin LivaNova 3T Heater-Cooler System lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-3417 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have a claim, we will start immediately.
WARNING: There are strict time deadlines for filing heater-cooler lawsuit claims.