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Stöckert 3T Heater-Cooler Devices

Patients who have recently undergone cardiothoracic (open-chest) surgery during which a Stöckert 3T Heater-Cooler system was used should be aware of a potential infection risk that has been linked to this device.

On October 13, 2016, the Food and Drug Administration (FDA) released a safety communication warning that surgery in which these devices are used had been linked with Mycobacterium chimaera (M. chimaera) infections. These are dangerous infections that can cause serious illness and even death.

According to The Washington Post, in the past year, at least 28 cases of M. chimaera infections have been identified at hospitals in Iowa, Michigan, and Pennsylvania. More have been reported in patients in Europe.

The FDA has warned doctors and hospitals to immediately remove any of these devices that have tested positive for the bacteria from their facilities, and to consider limiting the use of these devices until the manufacturer has found a way to mitigate the risks of patient infection.

Patients, meanwhile, are being told to watch for potential symptoms of infection, including persistent fatigue, fever, and muscle pain.

What are Heater-Cooler Devices?

Heater-cooler devices (HCDs) (also called heater-cooler units or HCUs) are medical machines used during cardiothoracic surgeries, including open-heart surgery, coronary artery bypass surgery, heart valve surgery, and surgery for lung cancer. They are designed to help warm or cool the patient during surgery, to keep the patient’s organs and circulating blood at normal temperatures.

These devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Though the water never comes into contact with the patient, the devices do have fans and exhaust vents. There is the potential for contaminated water to enter other parts of the device and aerosolize, and that contaminated air can then circulate into the surgery room where it can contaminate a patient going through cardiothoracic surgery.

The Centers for Disease Control and Prevention (CDC) notes that more than 250,000 heart bypass procedures using HCDs are performed in the U.S. each year, and that heater-cooler units are part of these procedures because they keep the patient’s circulating blood at a safe temperature.

What are Stöckert 3T Heater-Cooler Devices?

Stöckert 3T HCDs represent about 60 percent of the U.S. market. They have been available since 2006, and are manufactured by LivaNova PLC, formerly Sorin Group Deutschland GmbH. The FDA estimates that there are currently about 2,000 of these devices in use in the U.S.

The manufacturer advertises the devices as efficient heating and cooling machines with compressor-based cooling and 3 independent water tanks that eliminate the need for ice and water supply in the operating room. They add that temperature settings “can be adjusted to the tenth decimal point for accurate temperature control.”

On October 13, 2016, however, in response to the FDA and CDC warnings, the company released a “field safety notice update” warning surgeons and hospitals of potential risks associated with the machines. They noted that they had “learned a great deal” over the past two years about the infection risk to open-heart surgery patients.

Stöckert acknowledged the CDC’s tests of certain 3T HCD’s that showed a “genetic similarity between both patient and heater cooler strains of the NTM bacteria M. chimaera isolated in Iowa and Pennsylvania.”

They added that they were “continuing to analyze” the data, would work with the CDC and FDA to facilitate their recommendations for reducing the risk, and would “develop solutions to further mitigate the potential risk of NTM contamination.”

Heater-Cooler Devices Increase Risk of Infections

chimaera is a type of nontuberculous mycobacterium (NTM) classified as “slow-grower.” These organisms are naturally occurring and are found in water and soil. They are usually not dangerous to humans unless they are inhaled or if they enter the chest or lungs in another way, such as during surgery.

In most people, the organisms are cleared from the lungs naturally and don’t cause infections, but in people with weak immune systems, or who undergo these types of open heart surgeries, the risk of infection is greater. The CDC states that available information so far indicates that patients who had valves or prosthetic products implanted are at a higher risk.

In a 2016 study, researchers identified HCU’s as the source of Mycobacterium chimaera causing surgical site infections. They used a thermic anemometer and particle counter to investigate the transmission of the bacterium in an operating room equipped with an ultraclean airflow ventilation system. The culture plates less than five meters from the unit tested positive for the bacteria. They concluded that their results confirmed “airborne transmission of M. chimaera aerosols from a contaminated HCU to an open surgical field despite ultraclean air ventilation.”

In another 2016 study, researchers found a link between M. chimaera samples taken from several European infected patients, from the HCUs used during their procedures, and from environmental samples from Sorin’s HCU production and servicing facility in Germany. Researchers concluded that at least some of the M. chimaera infections may have been caused by HCUs that were contaminated at the manufacturing site.

Heater-Cooler Infections are Serious and Can Be Deadly

What’s particularly dangerous about these NTM infections is that because they’re slow growing, they can develop for months and even years without detection. The CDC warns that patients who have been exposed through open-heart surgery can “develop general and nonspecific symptoms that can often take months to develop.”

That means that without being aware of the issue, diagnosis can be missed or delayed, sometimes for years. During that time, the bacteria continue to grow, so that when the infection is finally detected, it is usually more difficult to treat.

So far, there is no blood test or other type of medical test to determine for sure that a person has been exposed. Only a laboratory culture can result in a specific diagnosis, but it can take months for the bacteria to grow enough for a culture to detect the infection.

The company has been aware of infections and even deaths linked to these devices since no later than 2014. Consumer Reports noted that at Greenville Memorial Hospital in South Carolina, officials identified at least 15 patients who were diagnosed with rare infections after heart and lung operations. Four of them died. An investigation traced the infections to the HCDs used in the operations.

Similar incidents have been reported in Iowa, Michigan, and Pennsylvania, and between January 2010 and February 2016, the FDA received 180 incident reports related to HCDs around the world. These reports include 16 U.S. hospitals across 10 states, where at least 45 patients were infected and at least nine died.

Most of these infections have been linked to the Sorin Stöckert 3T HCD, which is manufactured in Europe.

The FDA and the CDC caution that patients who have gone through open-heart surgery should notify their doctor immediately if they experience any of the following symptoms:

Night sweats
Muscle aches
Weight loss
Fatigue
Unexplained fever
Difficulty breathing
Persistent cough or cough with blood

Other infection-related complications that can occur up to four years after surgery include:

Surgical site infection
Endocarditis (inflammation of the inner lining of the heart)
Abscess
Hepatitis (inflammation of the liver)
Renal insufficiency (kidney problems)
Osteomyelitis (inflammation in the bone)
Splenomegaly (spleen enlargement)
Pancytopenia (deficiency of red and white blood cells and platelets at the same time)
Bacteremia (bacteria in the blood)

FDA Tracks Problem of Stöckert 3T Heater-Cooler Device Infections

This issue of HCU-related infections has been going on for awhile.

Back in the spring of 2015, for example, investigators in Switzerland reported that six patients developed M. chimaera infections after going through open-heart surgeries in which contaminated HCU devices were used.

In June of the same year, a Pennsylvania hospital also identified a cluster of NTM infections among open-heart surgery patients. Investigators working with the CDC identified an association between the infections and exposure to a contaminated Stöckert 3T HCDs, all manufactured by LivaNova PLC. That investigation prompted the notification of 1,300 patients of the potential dangers.

Subsequent tests of the devices, together with the report from Germany noted above, suggested that the contamination had come from the 3T HCD manufacturing site. Additional comparisons between patient specimens and device samples from facilities from various regions of the U.S. are “ongoing,” according to the CDC.

In October 2015, the FDA released a safety communication warning that the use of HCDs had been associated with NTM infections, “primarily in patients undergoing cardiothoracic surgical procedures.” They added that in some cases, patients presented with infections “several months to years after their surgical procedures.” They recommended that facilities and staff strictly adhere to cleaning and disinfection instructions, and to use only sterile water to rinse, fill, or refill the tanks.

The company also notified hospitals around this time, and disseminated updated cleaning instructions for the devices, but those instructions were later found to be inadequate in reducing risk of infections.

In December 2015, the FDA issued a warning letter to the manufacturer after inspections of several of their facilities revealed significant problems, including quality system and premarket clearance violations. They also placed an import alert on the devices to restrict how many come into the U.S.

In June 2016, the FDA released an updated safety communication warning surgeons, hospital staff, and patients of potential infections associated with the use of the Stöckert 3T HCD. This time, they revealed that testing by the manufacturer back in August 2014 found M. chimaera on the production line and water supply at the 3T manufacturing facility. In response, the company added new cleaning and disinfection procedures to the production line in September 2014. Samples taken in June 2015 showed no bacteria contamination.

The FDA recommended that facilities that purchased and used the 3T prior to September 2014 be aware that the units may have been shipped from the factory contaminated with M. chimaera.

Finally, in October 2016, the FDA released another safety communication, warning that health care facilities should take additional steps to help mitigate the risk of infections associated with 3T HCUs. Specifically, they recommended that any facility with devices manufactured prior to September 2014 should “strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection.”

The FDA noted that it was continuing to evaluate infections associated with heater-cooler devices, primarily in patients going through open-heart surgery. They also added that they’re still working to determine the cause of these infections, one of which may be the heater-cooler design.

Stöckert 3T Heater-Cooler Device Lawsuits

Patients who went through cardiothoracic surgery and then suffered from a serious infection may be eligible to file a Stöckert 3T Heater-Cooler device lawsuit.

Patients may be unaware of which device was used in their surgery. Chaffin Luhana provides consultations and case evaluations to help determine which device was used, and whether patients may have a case against LivaNova PLC.

Call today at 1-888-316-2311.



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