The heater-cooler system (Stockert 3-T) is used during cardiac procedures to control the body temperature of a patient during open heart surgeries. Because the 3-T Heater-Cooler system has been shown to circulate the M. chimaera bacteria, which can cause life-threatening infections, the US Food and Drug Administration (FDA) and US Centers for Disease Control & Prevention (CDC) has recently issued a warning regarding the risk of infection associated with the device.
The Centers for Disease Control and Prevention (CDC) has estimated more than 500,000 (half a million) patients who had open heart surgeries since 2012 could be at risk for the M. chimaera infection that is linked to the use of the Stockert 3-T Heater-Cooler.
More than 250,000 heart bypass procedures are performed each year in the United States, and this is the procedure where the Stockert 3-T is most commonly used. It is estimated that 60% of those procedures use this heater-cooler model.
Important Information From The CDC
Here is an excellent video from the CDC explaining the issue of the M. chimaera contaminated Stockert 3T heater-cooler units.
Bacteria Species in the World
More than 35,000 bacterial species have been sequenced, and it is estimated that hundreds of millions, maybe even billions, of species of bacteria exist on earth. When it comes to mycobacteria, more than 190 species have been identified. These include M. leprae, which is the bacteria that causes leprosy, M. tuberculosis, which, as the name suggests, causes tuberculosis, and the nontuberculous mycobacetria (NTM).
When it comes to NTM, more than 150 species have been identified, including M. fortuitum, M. abscessus, and the “avium complex” mycobacteria. Mycobacterium avium complex (MAC) is comprised of a number of species, including M. chimaera, which is the cause of the “signature” infection linked to the Stockert 3-T Heater-Cooler system.
The image below depicts the relationship of the various mycobacteria.
What is M. Chimaera?
Mycobacterium chimaera, or M. chimaera, is a group of bacteria known as non-tuberculosis mycobacteria (NTM) that can all be commonly be found in the environment, like in water and soil. It is only in very rare cases that M. chimaera causes infections in people. The fact is that infections have a tendency to develop very slowly and in people with a higher susceptibility to infections as a result of other health conditions.
M. chimaera may result in serious infections in patients who are very ill, including those whose immune systems have been compromised, or patients with underlying conditions like diabetes or are undergoing chemotherapy.
There is also a higher risk of infection among patients who are exposed to the M. chimaera bacteria while they are undergoing invasive medical procedures, such as heart valve replacement surgery. The bacteria can lead to serious chronic lung infections in, as mentioned above, patients with compromised immune systems. In some cases, it even causes death if it is left untreated.
Symptoms of M. chimaera Infections
M. chimaera infections grow very slowly, and as a result of this, it can take from a number of months to one year for an infection to develop. Some of the most common symptoms that patients report with this infection after undergoing open heart surgery are unusual or increasing shortness of breath, persistent fevers, and unexplained weight loss.
Other signs that a patient might possibly be infected with M. chimaera may include the following:
- Persistent cough or cough with blood
- Muscle pain
- Night sweats
- Abdominal pain
- Heat, redness, or pus at the surgical site
- Joint pain
If you or someone you know experiences symptoms, you should contact a doctor and let them know that you recently had open heart surgery.
Is M. chimaera contagious? You do not have to worry about M. chimaera infections as they are not contagious and do not spread from one person to another. You should also keep in mind that there is no test to show if healthy people are at risk of developing the M. chimaera infection in the future.
Treatment for M. chimaera Infections
Combinations of certain antibiotics can be used to treat M. chimaera infections. In some cases, prolonged treatment may be required for patients who have the infection – treatment may last from months to years.
Additionally, in rare cases, additional surgery may be needed for a few heart valve patients who contract M. chimaera infections soon after they have undergone cardiac surgery. If it is not treated as soon as possible, M. chimaera infection could turn fatal.
After speaking with a well known law firm handling M. chimaera lawsuits, our staff was able to learn a bit more about the usual treatment options for these infections.
According to the lawyers at Johnson // Becker, “The typical course of treatment, once they identify or suspect a M. chimaera infection is an IV antibiotic mix of Azithromycin, Rifampin/Rifabutin, Ethambutol, Amikacin, and Vancomycin (occasionally also including Moxifloxacin). Not all of these are always used, but the main 3 are going to be Azithromycin, Rifampin/Rifabutin, and Ethambutol. Treatment is scheduled for a year to “indefinitely” depending on patient progress.
“The Stockert 3T lawyers at the law firm went on to tell us, “It always starts out as an IV treatment during the injured persons hospital stay. Depending on how well they do, at the end of their stay, they may switch to oral antibiotics or they may keep you on home IV infusions. If the patient is healthy enough, the doctors will most likely opt for a re-do surgery to take out the infected cardiac device, usually a heart valve. Our law firm thinks that this usually gives the best chances of recovery but only your doctor can make these decisions, as each persons infection is unique.”
Before an open-chest surgery, you should always sit down with your doctor and discuss the risks and benefits of your procedure. For most patients, the benefit of getting a cardiac procedure that their doctor has recommended far outweighs the risk of infection. Make sure that you ask your doctor what to expect after your surgery is completed and when you should seek medical attention.
CDC Recommendation for Diagnosing & Treating M. chimaera Infections
According to the CDC, “these infections can be challenging to diagnose and treat. Patients have presented with a variety of clinical manifestations including endocarditis, surgical site infection, or abscess and bacteremia. Other clinical manifestations have included hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis. Patients have also presented with granulomatous disease and have been misdiagnosed with sarcoidosis. CDC recommends that physicians consult with an infectious disease specialist for specific clinical concerns regarding these infections.”
What are Heater-Cooler Systems?
Also known as heater-cooler units (HCUs) or heater-cooler devices (HCDs), heater-cooler systems are devices that are often used while doctors perform cardiac surgery because the organs and circulating blood need to be maintained at specific temperatures. They are used during cardiothoracic surgeries, including heart valve surgery, coronary artery bypass surgery, open heart surgery, and lung transplant procedures.
Heater-cooler units have water tanks that supply water that is temperature controlled to heat exchangers external to the unit or to cooling/heating blankets via closed circuits. Though the water in these units and the patient never come into contact with each other, the units have exhaust vents and fans.
Water that is contaminated from within the unit can aerosolize it as it makes its way through the closed circuits. The exhaust vents can then push that contaminated air into the operating room and this in turn can cause contamination of the patient who is undergoing the surgery.
Heater-Cooler Unit Brands Used in Surgeries
There are a large number of manufacturers that are responsible for producing and marketing a wide range of different brands of heater-cooler devices that are used in surgical procedures. The Stockert 3-T, built by German manufacturer Sorin, was the most commonly used heater-cooler device model in the United States at the time of the infections. In June 2015, there was a merger between Sorin and Cyberonics, Inc. and the new company was named LivaNova.
LivaNova’s Stockert 3-T heater-cooler device is the model used in approximately 60% of close to 250,000 surgeries that require a heater-cooler device, performed each year in the US and it has been linked to the spreading of nontuberculous mycobacteria (NTM). Other brands and manufacturers of heater-cooler units used in surgeries include:
- CSZ Hemotherm 400MR
- Biotherm Heat Exchanger
- ECMOtherm II Heat Exchanger
- Terumo HX@ Heater/Cooler
- Thermoguard XP (Alsius Corporation)
- Jostra HCU 30 (Jostra AB)
- Heater-Cooler Unit HCU 40 by Maquet Brand
- Terumo Sarns TCM II
Although these other brands exist, the Stockert 3-T is the model that has been directly linked to a series of M. chimaera infections.
Types of Surgical Procedures that Use the Stockert 3-T Heater-Cooler Device
Cardiothoracic surgeries involve any procedure that has to do with the heart, esophagus, lungs, and other organs in the chest. Thoracic surgeries – involving the part of the body between the neck and the abdomen, mainly the chest – are performed in most cases to treat the esophagus, lungs, and chest wall.
On the other hand, cardiac, or heart, surgeries are performed to treat the arteries in the heart and chest, heart valves, and of course, the heart.
The types of surgeries that utilize the Stockert 3-T heater-cooler unit include:
- Lung cancer
- Esophageal cancer
- Benign tumors and diseases of the lung
- Benign tumors in the esophagus
- Chest reconstruction
- Esophageal reconstruction
- Gastroesophageal reflux – which is a digestive disease in which the lining of the esophagus is irritated by stomach acids
- Pleural diseases, or diseases of the lung membranes
- Excessive sweating
- Chest wall tumors
- Lung transplant
- Heart transplant
- Stent insertion for narrowing airways
- Angioplasty – surgery for repairing or unblocking a blood vessel
- Atherectomy – surgery performed to remove build-up of cholesterol, fats and other substances, or atherosclerosis, from blood vessels
- Artificial heart valve surgery – surgery performed to replace a heart valve that is damaged with a functioning one
- Stent insertion to open arteries, relieve angine or chest pain, or improve blood flow
- Bypass surgery – a procedure that takes veins or arteries from other parts of the body and uses them to reroute blood around an artery that is blocked
- Cardiomyoplasty – a procedure in which healthy muscle from another body part is wrapped around the heart
Contamination from Heater-Cooler Devices
As mentioned earlier, the water from the Stockert 3-T does not directly come into contact with the patient. However, the probability for a source of contaminated water to seep into other parts of the unit or transmit the bacteria through the air around us does exist. Aerosolization occurs and airborne bacteria can filter into the environment and the patient while a surgical procedure is being performed.
Some of the factors that can increase NTM bacteria aerosolization include:
- Bubbling or agitation of water inside the tank through heart-lung machines, or pumps
- Return circuit water
- Mixing components
Some additional device-specific and environmental factors that may weigh in include the following:
- Constant Streamline or Laminar Flow Disruption: In this case, the location and positioning of the exhaust fan of the heater-cooler device may come into play.
- Air Filters: Some heater-cooler units have air filters while others do not. But it is unlikely that most are able to capture NTM bacteria.
- Fans: These are present in most heater-cooler units and may facilitate the movement of NTM bacteria that have aerosolized from the unit into the operating room.
Water Filters: Not every heater-cooler device has fans either. But they should be able to remove a lot of the NTM bacteria from tap water that is used in the unit.
Risks for People Having Open heart Surgery
There have been extra measures put in place in order to lower the chances of patients developing a Mycobacterium infection during open heart surgery, but there is still the possibility of a very small risk. The risk of infection from M. chimaera bacteria is very low, and it is much lower than the risk of heart problems not being treated appropriately. Hence, doctors will usually not recommend delaying surgery.
As mentioned earlier, if you are going to have open heart surgery, you should talk to your doctor about the risks that are involved with the procedure, including Mycobacterium chimaera infection.
Heater-Cooler Infections are Serious and Can Be Fatal
NTM infections are particularly dangerous as they grow very slowly and can take months and even years for patients to start experiencing symptoms. According to a warning by the Centers for Disease Control and Prevention (CDC), patients who have been exposed to the M. chimaera infection through open heart surgery can develop symptoms that are general and nonspecific that can often take a number of months to develop.
Are M. chimaera Infections the Manufacturer’s Fault?
Investigations that have been conducted into the cause of the contaminated Stockert 3-T Heater-Cooler devices have yielded some insights that have been troubling, indicating negligence on the part of LivaNova, PLC, the manufacturer of the 3-T.
LivaNova conducted its own testing for M. chimaera in August 2014. It is important to note that the manufacturer conducted this internal testing well before the initial awareness of the FDA of such infections, as well as before the FDA inspected the devices and issued safety communications about the Stockert 3-T Heater-Cooler.
It has been revealed that LivaNova already had knowledge about M. chimaera contamination within the production line and water supply in their facility but failed to pull the potentially contaminated devices off the market. The company also continued to distribute the potentially contaminated Stockert 3-T units all over the world. Thus, surgeries that were performed from 2012 to 2016 were still utilizing these potentially contaminated devices.
Why are Lawsuits Being Filed Against the Manufacturer?
The manufacturer of the Stockert 3-T Heater-Cooler devices, LivaNova, PLC, was aware that these units were potentially contaminated with a deadly bacteria, yet continued to distribute and sell them all across the globe. Lawsuits that involve the 3-T device are now being filed on the following grounds:
- Failure to Warn: The manufacturer failed to properly warn health care providers of the known risks of the Stockert 3-T Heater-Cooler device.
- Failure to Design a Reasonably Safe Device: The Stockert 3-T device was not designed in such a way that the water tank and internal circuits could be cleaned and disinfected, which in turn allowed for the formation of biofilm on parts of the device.
- Failure to Have Adequate Procedures for Cleaning and Disinfection for Manufacturing Process: The manufacturer did not have adequate cleaning and disinfecting procedures for the manufacturing process as the FDA detailed in its warning letter and inspection findings.
A class action lawsuit involving the Stockert 3-T Heater-Cooler device was recently filed in Pennsylvania federal courts, seeking class action status for more than 3,600 patients who had undergone surgical procedures at hospitals in Pennsylvania. Since then, other claims are beginning to be filed in a number of other courts across the United States as well.
Why You Should Consider an Individual Lawsuit to Pursue Financial Recovery Over a Class Action Lawsuit
As mentioned already, an M. chimaera infection has potentially deadly consequences and is life-threatening. When patients develop an infection that has a 50% mortality rate, it can have devastating results and it requires nothing less than the finest treatment and care of infectious diseases.
Unfortunately, many people have already been infected or have lost loved ones to the deadly infection as a result of the potential negligence of the manufacturer of the device that failed to warn health care providers about the problems involving M. chimaera contamination.
If you or a loved one has been infected by the M. chimaera bacteria, you should pursue financial recovery by filing an individual lawsuit instead of opting for a class action lawsuit. An individual claim or settlement can yield far greater financial recovery than if you participate in a class action suit or settlement.
How an Individual Lawsuit can Benefit You
The devastating M. chimaera infection can have an equally devastating effect on your health and well-being, or that of your loved one. It can have a significant impact on your physical and emotional health as well as financial status.
The truth is that you or your loved one should not have to bear this burden as a result of the negligence of the manufacturer of the device that could have prevented the hardships you are going through from occurring in the first place.
Manufacturers of medical devices are subject to strict guidelines and rules by the US Food and Drug Administration (FDA). It puts rules in place requiring manufacturers to have adequate cleaning and disinfection procedures for the device as well as requiring procedures for the extensive testing and reporting of their device’s safety.
The rules laid out by the FDA must be met even before the manufacturer can sell the device to hospitals and before it can be used in hospital operating rooms.
These requirements are set up so that surgeons and other medical professionals in hospital clinics can weigh the many benefits of a certain heater-cooler unit against the potential dangers and the repercussions that it may cause. It also allows health care providers to make an astute decision about the brand heater-cooler unit that they should put to use during surgeries based on the availability of safety data collected in pre-marketing testing and trials.
Negligence of a Manufacturer in Regards to the Safety of a Medical Device
Because the Stockert 3-T Heater-Cooler device has resulted in a large number of patients developing the life-threatening M. chimaera infection, patients are burdened with extremely high medical expenses, loss of income, a decrease in quality of life, and much more. The negligence of the manufacturer of the medical device has devastating consequences on the lives of infected patients.
If you are one of the victims of this negligence, you can claim for what are referred to as “damages”, a legal term used for the financial compensation that you can be awarded when you file an individual lawsuit or are a part of class action lawsuits. In many cases you may also be able to receive an out-of-court settlements.
Your Next Step if You are Infected by the M. chimaera Bacteria
If you or a loved one has developed the M. chimaera infection, you should immediately seek the help of an attorney with the acumen and knowledge in medical device liability cases.
Your legal counselor will review the available evidence and thoroughly evaluate your case before determining if you have a viable case. If you do, they will begin the steps to file your claim for a defective medical device. They will consult with and bring in expert witnesses to testify on your behalf.
It is important to bear in mind that you will be going against a large medical device company who can afford to hire the best and most expensive lawyers. They will do everything they can to delay and hamper the case against them. However, with your attorney and their law firm’s help, you can have the resources and skills needed to take on the major company and hold them accountable for their negligence and putting profits over the lives of people.
If you have been infected due to a Stockert 3-T Heater-Cooler device during a surgery, you should make sure that you do a little research and find an attorney who has taken on cases like yours and is not afraid to fight large companies and prove their negligence. You need someone who knows what a strong case looks like and knows the tactics the other side will likely employ.
With a judicious and proven defective medical device attorney by your side, you can make sure that you recover damages and gain compensation for the care and treatment you will need due to this deadly infection.
Don’t worry about costs. The Stockert 3T heater cooler lawyers associated with Advocacy For Patients offer a Free Confidential Case Evaluation. Time is limited in these claims, so contact an attorney right away to discuss your individual situation.
To contact a lawyer for a Free Case Evaluation, please fill out the form below or visit the Stockert 3T Lawyers at Johnson // Becker, PLLC by visiting the following link: