The Stockert 3T Heater Cooler is a machine used during open heart surgeries to control a patient’s body temperature. The FDA recently issued a warning of infection risks associated with the device. The Stockert 3T has been shown to circulate a rare bacteria known as M. chimaera, which can cause life threatening nontuberculous mycobacteria infections (NTM). Research has shown that this bacteria, or biofilm, formed on the inner surfaces of this device during the manufacturing process in Europe. This development has outraged patients who suffered infections after undergoing surgeries that used Stockert 3T Heater Cooler machines.
Stockert 3T Heater Cooler Infections
When a patient undergoes a surgical procedure, they are entitled to a reasonable expectation that the room and the tools used be clean, in order to prevent infection. The Stockert 3T Heater Cooler machine compromised both of these rights. This device uses a water tank and an air circulation system to warm and cool a patient’s blood during surgery. However, it is this air circulation system that is thought to spread the deadly M. chimaera bacteria into operating room’s air supply; causing a variety of complications including nontuberculous mycobacteria infections (NTM).
What are Nontuberculosis Mycobacteria?
Nontuberculous mycobacteria (NTM), also known as as environmental mycobacteria, mycobacteria other than tuberculosis (MOTT) or atypical mycobacteria, are types of mycobacteria which do not cause tuberculosis or leprosy. NTM can cause cases of pulmonary diseases that mirror the symptoms of tuberculosis. NTM disease most often presents as lung disease, but lymphatic, skin/soft tissue, and disseminated disease have also be attributed to NTM. Symptoms of NTM disease vary widely and are often generalized in nature, making them extremely hard to diagnose (which is why it is thought that it took so long for doctors to draw the parallels between the Stockert 3T Heater Cooler and the infections patients were suffering from.)
Nontuberculosis Mycobacteria Symptoms
People who have been infected with Nontuberculous mycobacteria (NTM) often undergo a frustrating and painful road to recovery. This is because this rare form of bacterial infection is not generally included on infection culture tests. The disease also presents a broad set of symptoms that are easily mistaken for other conditions. However, if you or a loved one has experienced two or more of the following symptoms after undergoing a heart surgery, contact your health care provider immediately:
- Weight loss
- Lack of appetite
- Night sweats
- Blood in the sputum (phlegm)
- Loss of energy
Like tuberculosis (TB), nontuberculous mycobacteria (NTM) infection also affects the lungs. Because of that, the condition is often mistaken for TB initially. Only a doctor can properly diagnose and treat TB and NTM infections.
Stockert 3T Heater Cooler And The FDA
The Stockert 3T Heater Cooler system has been under scrutiny from the FDA for years, but only recently did the federal agency issue a comprehensive look into how the machine was causing Mycobacterium chimaera (M. chimaera) infections. In a report published in October of 2016, FDA intended to “help prevent the spread of infection related to the use of these devices.” The paper drew into question the safety of LivaNova PLC’s device by saying,
“Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.”
The report went on to detail an admitted link between M. chimaera infections and the 3T system, by the device’s own manufacturer.
“Testing conducted by the manufacturer in August 2014 found M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.
The 3T devices manufactured at this facility were distributed worldwide.
In response to the M. chimaera findings in August 2014, the manufacturer added cleaning and disinfection procedures to the production line in September 2014. Samples taken at the same manufacturing facility, by the German Regulatory Authorities in July 2015 did not show M. chimaera, potentially indicating the contamination at the manufacturing facility had been resolved. Although the manufacturer of 3T devices added cleaning and disinfection procedures to the production line in September 2014, the FDA is now aware of some 3T devices manufactured after September 2014 which have tested positive for M. chimaera. It has not been confirmed whether these devices were contaminated at the manufacturing facility or became contaminated at the user facility.”
All of this information concluded in a set of warnings for doctors and hospitals using the 3T system:
“If your facility uses 3T devices, you should:
- Immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known M. chimaera patient infections at your facility.
- Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
- Be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
- Review the recommendations in CDC’s Health Advisory
- Be aware that heater-cooler devices are important in patient care. In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.
If your facility has 3T devices manufactured prior to September 2014, you 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.
- Use of these devices should be limited to emergent and/or life-threatening situations if no other heater cooler devices are available.
- Follow the FDA’s earlier recommendations to help mitigate the risks of patient infection.
- Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.
These devices have been shown to cause serious complications that often go undiagnosed for considerable lengths of time, causing undue suffering to patients who had no prior knowledge of their increased risk of infections due to the 3T system. Because of this, a number of men and women diagnosed with NTM infections have begun to file lawsuits against LivaNova PLC, in an attempt to hold the medical giant accountable for their devastating injuries.
Stockert 3T Heater Cooler In Review
It is estimated that thousands of men and women have contracted NTM infections due to M. Chimaera bacteria, due to faulty Stockert 3T Heater Cooler machines used during heart surgery. These people have often undergone painful, frustrating roads to recovery due to misdiagnoses and false-negative test results and some have died as a result of the contaminated product. The 3T product is used in close to 60% of all open heart surgeries in America. Patients across America, who have been diagnosed with NTM infections, have begun to file lawsuits against LivaNova PLC. These lawsuits claim that the device giant did not take adequate steps to protect the patients that their devices were designed to save. At the time of writing, the FDA has yet to issue a formal recall against the 3T machines, even after their own somber warning that doctors and hospitals 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.”