The Sorin 3T Heater Cooler System is an advanced medical device used in operating rooms around the world. The machine regulates the patient’s body temperature during complex heart surgeries that require the heart and the flow of blood to be stopped during the procedure. Germany-based LivaNova Inc, the manufacturer of Sorin 3T Heater Cooler, created the device that uses three unique circuits to make sure the patient’s body is sufficiently heated or cooled throughout the surgery. However, in recent years, the machine has been linked to TM (non-tuberculosis mycobacteria) infections and other severe side effects.
Since the end of 2016, the manufacturer of the device, the Centers for Disease Control and Prevention (CDC), and hospitals throughout the U.S. have warned patients who have undergone cardiopulmonary operations involving the Sorin 3T Heater Cooler System. Their urgent warnings have informed patients of the potential risk of exposure to Mycobacterium chimaera contamination involving deadly bacteria that could potentially grow in the device’s water tank. If the bacteria are present, they can aerosolize from the machine and spread throughout the OR (operating room) and into the patient’s chest opened cavity through the air or through a transfer onto surgical tools.
How Does the Heater Cooler Device Work?
The heater cooler device is a crucial component used in invasive complicated open-heart surgeries like heart transplants, valve replacements, and bypass procedures. This is because the unit helps regulate the body’s organs to ensure it sustains a safe temperature while maintaining proper blood flow circulation. Nearly 250,000 complex cardiac surgeries are performed in America each year where approximately 60% of these highly invasive surgical procedures require a heater cooler device.
The device requires water that is stored in a tank maintained at a specific temperature to either cool or heat the patient’s body and blood when necessary. However, studies have shown that the defective design of the device allows non-tuberculosis mycobacteria to grow. While the water does not come into direct contact with the patient’s body, it does aerosolize (vaporizes) before being released into the open air, spreading and contaminating the sterile environment.
Non-Tuberculosis Mycobacterium Infection Symptoms
Since the Sorin 3T Heater Cooler System was approved for use in cardiac surgeries, more than 500,000 patients have been exposed to the potentially deadly bacterial infection. One research study conducted by the CDC revealed that approximately fifty percent of all patients who developed NTM infections will likely die from Mycobacterium chimaera.
Unfortunately, many of the signs and symptoms associated with NTM infections are not always apparent immediately after the surgery. In fact, some patients develop the serious infection months or years following their highly invasive cardiac procedure. This extended period of time can make a challenging for the doctor to diagnose the condition accurately and provide beneficial treatment when possible. In short, the diagnosis of a Mycobacterium chimaera infection comes too late to save the life of the patient.
The common symptoms associated with non-tuberculosis Mycobacterium chimaera include:
- Surgical site infection
- Endocarditis involving endocardium inflammation
- Bacteremia involving the development of bacteria in the bloodstream
- Abscess – Localization of accumulated pus around inflamed body tissue
- Renal insufficiency – A chronic or acute kidney problem involving poor renal function
- Hepatitis – Liver inflammation
- Osteomyelitis – Bone marrow or bone inflammation
- Pancytopenia – Red cell, white cell, or platelet blood deficiency
- Splenomegaly – Abnormal spleen enlargement
- Unexplained sudden weight-loss
- Unexplained fever
- Achy muscles
- Night sweats
Doctors attempt to fight the infection using powerful antibiotics. However, the results of antibiotic treatments on Mycobacterium chimaera has not been effective in many cases. Some patients have undergone infected heart valve or heart tissue replacement to stop the growth of infection.
The FDA and CDC Input on Sorin 3T Heater Coolers
Since October 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have reported the correlation between the Sorin 3T Heater Cooler System and the deadly bacteria. The CDC reports that even though thousands of individuals have received notification of the potential risk of bacterium associated contamination from heater cooler devices, this number of patients who could acquire an infection could grow exponentially in the years ahead.
On October 14, 2016, the U.S. Food and Drug Administration issued a Safety Communication to alert healthcare providers what was happening and the steps needed to reduce the potential spread of infection known to be spread by this device. That same month, the Washington Post published an article over concerns of the deadly bacteria. The article suggested that thousands of patients had been notified of the potential risk of developing the infection. Of these patients, many had undergone some procedure that required the chest to be opened. The article noted that of the twelve patients who had undergone surgical procedures at a Pennsylvania Hospital who ultimately developed in deadly non-tuberculosis Mycobacterium infection six of those patients succumbed to the bacteria even after being treated.
However, even though federal regulators became aware of the deadly infection associated with heater cooler devices back in 2014, it took more than fourteen months for them to take any action to alert the public, causing many more patients to be exposed to the deadly bacteria. Even then, it took many more months for regulators to release detailed recommendations to doctors, patients, and hospitals on how to treat the condition. Many critics state that thousands of lives could have been saved and many more thousands could have avoided ongoing courses of antibiotic treatment had they never been exposed to the harmful deadly bacteria.
Both federal health agencies have not yet determined why non-tuberculosis Mycobacterium is any more resistant to antibiotics than other bacteria. To ensure patients are receiving adequate treatment, some doctors prescribe several forms of antibiotics like rifabutin, clarithromycin, and azithromycin to be taken concomitantly. However, there are multiple strains of the bacterium and some of those are much easier to kill using antibiotics than others. Some patients have undergone surgical procedures to remove diseased implants or tissue infected by the bacteria.
An Ongoing Problem With Heater Cooler Devices Used in Surgeries
A spokesman for LivaNova Inc, the device’s manufacturer, states that “We are working with regulators to develop a solution that addresses their concerns and ensures continued clinician access to this important device, which enables life-saving cardiac surgery.”
However, the potential for exposure to bacterium contamination when using heater cooler devices was first brought to the attention of the medical community back in 2002, when a research study was published. The study revealed that German hospital doctors had isolated “germs and particles polluting” the units. The medical team recognized that disinfecting the unit was extremely challenging. The study indicated that these units “do not provide any technology to reduce bacterial or other contamination” which can pose potentially severe consequences for an unsuspecting patient.
In April 2010, regulators from the Food and Drug Administration visited the LivaNova manufacturing plant in Germany to discuss safety concerns about the contaminated heater cooler machine. The manufacturer has suggested disinfecting the heater cooler once every two weeks. However, the overgrowth of bacterial contamination took approximately a day and a half.
This problem was hardly a surprise to the FDA who had received many reports of infections associated with heater cooler devices back in 2009 and 2010. However, that information is not available when searching the Food and Drug Administration public database. Even knowing the life-threatening problem was reported, it still took the FDA until mid-2014 to start their investigation, which was at approximately the same time that a rare infectious outbreak was first reported from a hospital in South Carolina. By 2015, the FDA came to understand the Heater Cooler devices when operating would blow the Mycobacterium chimaera throughout the sterile environment in the operating room.
Should You File a Lawsuit for an Infection Related to a Heating or Cooling Device?
Many individuals who have developed Mycobacterium chimaera infections were diagnosed with condition months or years after undergoing an open-heart procedure. To ensure they receive financial compensation for their damages, many of these patients have filed 3T heater cooler lawsuits against LivaNova Inc, the hospital and others responsible for their failure to conduct safety testing adequately and properly. Allegations noted in these lawsuits include:
- The device manufacturer developed the heater cooler machine using a faulty design that allowed colonies of bacteria to be spread throughout the operating room during complex invasive surgical procedures.
- LivaNova Inc manufactured and sold their Sorin 3T heater cooler device knowing that NTM contaminations were possible and could cause injury or death to the patient.
- LivaNova Inc failed to provide users proper cleaning and disinfecting procedures to ensure that the system remained free of infectious contamination at all times.
- The doctor, hospital and LivaNova Inc failed to provide patients adequate warning about the potential risk of NTM colonization and the spread of the bacteria by the defective design.
- LivaNova Inc failed to alert patients and doctors to test for an NTM infection promptly after undergoing invasive surgery using the 3T heater cooler device.
Hiring a Lawyer to Investigate and Prosecute a 3T Device
If you have undergone invasive open-heart surgery where a 3T heater cooler device was used, you are likely entitled to file a claim or lawsuit against LivaNova Inc, the hospital, doctor and other healthcare providers. The experienced Essure attorneys at the Drug Law Center can file and resolve your claim to ensure you are fairly compensated for your damages including current and future medical expenses, lost wages, mental anguish, pain, suffering, and loss of enjoyment of life.