Heater-Cooler Systems Lawyer

Heater-cooler systems are used during cardiothoracic surgery (open-heart surgery) and other medical procedures to warm or cool patients in order to optimize care and improve outcomes.

The heater-cooler devices feature water tanks that transport temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits.

The quiet running system is said to deliver effective blood temperature management control during cardiopulmonary bypass and other related cardiovascular procedures, according to Cincinnati Sub-Zero, a medical device company that manufactures the Hemotherm CE heater-cooler system.

However, according to multiple reports, it’s possible for the water used in several systems, including the 3T system — a heater-cooler device manufactured by LivaNova PLC — to become contaminated, which can result in bacteria, including nontuberculous mycobacterium, being released into the air through the system’s exhaust vent. As a result, patients may be been exposed to harmful bacteria.

If you or someone you love has contracted an infection from one of these devices, a heater-cooler systems lawyer can help you file a lawsuit. Our qualified dangerous device attorneys can guide you through each step of the legal process to demand justice.

Surgeries That May Include Use Of Heater-Cooler Device

The following types of surgeries may require or include the use of a 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

The LivaNova Stockert 3T is used in 60% of the 250,000 heart bypasses done in the U.S. every year.

Which Companies Manufacture Heater-Cooler Systems?

The following medical device companies manufacture heater-cooler systems:

• Sorin Stockert LivaNova 3T
• Terumo HX2
• Cincinnati Sub-Zero 333W and Hemotherm CE
• Maquet HCU20, HCU30, HCU40

LivaNova is currently conducting extensive testing and data collection in an effort to understand how nontuberculous mycobacterium (NTM) transmission may be occurring during the use of heater-cooler devices. According to the medical device manufacturer, the current thinking is as follows:

• The failure to clean and disinfect a water circuit of a heater/cooler can allow biofilm formation. Nontuberculous mycobacterium is known to proliferate in biofilm and may lead to contamination of the heater/cooler water circuit.

• In the operation of the heater-cooler device, air bubbles may be generated in the water tanks and then exit the device as aerosolized particles. The NTM present in the water may be carried by aerosolized particles out of the tank.

• Via airflow, the aerosolized particles may then be dispersed into the surrounding environment.

• The state of scientific knowledge provides no evidence that nontuberculous mycobacteriumcan be transmitted via water evaporation because water molecules formed by evaporation are too small to carry the bacteria.

In some cases, the contamination has been traced to LivaNova’s production facility in Germany. No matter which manufacturer created the heater-cooler system that caused your injuries or worsened medical condition, you should contact a lawyer to see if you can file a claim for compensation.

Maquet HCU System Heater-Cooler Devices

According to multiple reports, it’s possible for the water used in several systems, including the Maquet HCU system, to become contaminated, which can result in bacteria, including nontuberculous mycobacterium (NTM), to be released into the air through the system’s exhaust vent. As a result, patients may be been exposed to harmful bacteria.

The failure to clean and disinfect a water circuit of a heater/cooler can allow biofilm formation. Nontuberculous mycobacterium is known to proliferate in biofilm and may lead to contamination of the heater-cooler water circuit.

In the operation of the heater-cooler device, air bubbles may be generated in the water tanks and then exit the device as aerosolized particles. The NTM present in the water may be carried by aerosolized particles out of the tank. Via airflow, the aerosolized particles may then be dispersed into the surrounding environment. The FDA released its first warning about heater-cooler devices and NTM infections in October 2015.

In October 2016, Maquet announced issues with its heater-cooler devices.

Cincinnati Sub-Zero Devices

Cincinnati Sub-Zero — a subsidiary of Gentherm, the global market leader and developer of innovative thermal management technologies — is based in Sharonville, Ohio and comprised of three divisions: medical, industrial, and CSZ testing services.

Gentherm — a technology company with a focus on thermal technology — has locations in 12 countries, and more than 10,000 employees worldwide. The technology company designs, develops, and manufactures heating, cooling, and ventilating devices, including:

• Heated and cooled seating
• Heated steering wheels
• Heated and cooled cup holder
• Cool bin
• Interior surfaces

LivaNova 3T Heater-Cooler Devices

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.

About Cardiovascular Groups

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.

Sorin

Sorin — a 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.

Terumo Cardiovascular Group

Terumo Cardiovascular Group — based in Ann Arbor, Mich. — manufactures and distributes medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring, and vascular grafting. This includes a full line of perfusion products, endoscopic vessel harvesting products, and surgical stabilization products. Terumo CV Group is the exclusive distributor of Vascutek Vascular Grafts in the United States. The medical device manufacturer was established in 1921 and has more than 19,000 associates in 82 sales offices and 24 production facilities.

Why Are Heater-Cooler Devices Reportedly Dangerous?

The U.S. Food & Drug Administration (FDA) recently warned that heater-cooler systems used during open-heart surgery and other medical procedures may transmit bacteria and cause infections, such as mycobacterium chimera, resulting in severe injury or death.

Thousands of surgeries have allegedly been performed using contaminated heater-cooler equipment. Victims of harmful heater-cooler devices allege in lawsuits that the water in the heater-cooler system’s reservoir can become contaminated and spray into the air. As a result, severe — and possibly fatal — infections can result.

Claims are currently being filed against LivaNova PLC, the manufacturer of the 3T heating-cooling system, because the device has been found to transmit bacteria into patients during surgeries, namely open-chest cardiac procedures.

In addition to the FDA’s warning, the CDC also issued a warning about heater-cooler devices to healthcare providers and patients. 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. 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.

The FDA released its first warning about heater-cooler devices and NTM infections in October 2015.

Two months later, the federal agency sent a warning letter in December 2015 to the Sorin Group, maker of a heater-cooler device linked to infections and deaths at a Pennsylvania hospital. According to the FDA, the Italy-based company failed to provide adequate information regarding how its new cleaning procedures prevent biofilm from growing in the heater-coolers. To learn more, reach out to a heater-cooler systems lawyer to discuss your unique case and see if you qualify for a lawsuit.

CDC Issues Recommendations About Dangers of Heater-Coolers

The Centers For Disease Control and Prevention recently issued recommendations to health officials, healthcare providers, and facilities to keep an eye out for nontuberculous mycobacterium infections among patients who have undergone cardiac surgery and to take all necessary precautions in order to prevent such illnesses.

“The most important action to protect patients will be to remove contaminated heater-coolers from operating rooms, and ensure that those in service are correctly maintained,” the agency issued in a statement. “Patients who might have been exposed to NTM during a surgical procedure should continue to look for signs of potential infection and keep in touch with their clinicians for further evaluation. Due to the potentially long delay between exposure to NTM and manifestation of clinical infection (up to several years), identifying infections related to the use of heater-cooler devices can be challenging.”

Common Symptoms of Nontuberculous Mycobacterium Infections

Patients exposed to contaminated water in the heater-cooler device may experience the following side effects:

• Fatigue
• Unexplained fever
• Sudden weight loss
• Night sweats
• Muscle aches
• Myalgia
• Malaise
• Blood in the sputum (phlegm)
• Endocarditis
• Surgical site infection
• Abscess
• Bacteremia
• Hepatitis
• Renal insufficiency
• Splenomegaly
• Pancytopenia
• Psteomyelitis

Potential complications may occur up to four years after undergoing cardiac surgery. However, it is best to contact an attorney as soon as you discover any potential complications from a heater-cooler system.

A Heater-Cooler Systems Attorney Can Help

Our heater-cooler systems 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.

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
  • Fatigue
  • Fever, and
• Symptoms were severe and persistent enough for the client to seek medical treatment or
• Received a warning letter about the potential risk from the hospital where they had surgery or
• Diagnosed with a Mycobacterium Chimaera/nontuberculous mycrobacterium (NTM) infection