The FDA and CDC are warning patients and providers about the potential risk of infection from the Stockert 3T Heater-Cooler System used during open-chest surgeries involving the heart, lung or liver.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year. Heater-cooler units are an essential part of these surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure, yet most patients are not aware of the device’s usage.
For this reason, the CDC and the FDA are now warning patients who had open heart, liver or lung surgeries to seek medical care if they are experiencing symptoms associated with infections that could indicate they were exposed to M. Chimaera, a dangerous form of nontuberculous mycobacterium (NTM).
What is M. Chimaera?
M. Chimaera is a type of nontuberculous mycobacterium (NTM) classified as a slow grower. M. Chimaera can lay dormant for up to five years without symptoms. M. Chimaera is often found in soil and water but in the environment, it rarely makes healthy people sick. Patients who have been exposed to the bacteria through open-heart, liver or lung surgery can develop general and nonspecific symptoms that can often take months to develop.
Because M. Chimaera is slow growing, a diagnosis could require months of testing after initial exposure before a patient can rule out infection. As a result, diagnosis of these infections can be missed or delayed, sometimes for years, making these infections more difficult to treat.
M. Chimaera may cause serious illness or death.
Since patients are rarely aware of the usage of a heater-cooler device in their surgery, it is imperative that anyone who underwent a cardiopulmonary bypass procedure should discuss the possibility of exposure to this deadly infection with their health care provider to determine if further testing or monitoring is required. If any of the following symptoms are being experienced, contact your health care provider as soon as possible.
Signs and Symptoms of M. Chimaera (NTM) that should be reported to a medical professional immediately:
- Redness, heat, or pus at the surgical site
- Muscle pain
- Joint pain
- Night sweats
- Weight loss
- Abdominal Pain
Symptoms of NTM infection can present as several other infections/diseases and may lead to misdiagnosis. Some patients have been diagnosed with sarcoidosis, hepatitis, prosthetic valve endocarditis and vascular graft infection.
Treatment Options and Outcome from NTM Infection
According to Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion, “It is important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly.”
Extensive treatment is required for patients that are found to be infected. Current medical treatment recommendations include 3 months of an IV Antibiotic cocktail and 2 years of antibiotics. Known side effects from this course of treatment include hearing loss, vision loss, GI problems, and organ damage. In some cases, a health care provider might suggest surgery to remove infected valves.
Based on current information, death has been reported in more than 50% of infected patients.
Other Bacteria Linked to 3T Heating Cooling Device
- M. Abscessus – fast growing bacteria, multidrug resistance due to biological properties. Susceptible to few antibiotics
- Pseudomonas aeruginosa
How does a Heating-Cooling Device work?
Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. 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.
FDA and CDC Suggest Hospitals Should Warn Patients of the Risk of Infection to Mitigate Risk
According to the CDC, approximately 60 percent of heart bypass procedures performed in the U.S. utilize the Stockert 3T device that have been associated with these infections. In October 2016, the CDC estimated 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 CDC and the FDA are continuing to evaluate this risk and we may see the number of individuals at risk grow as it takes a significant amount of time to develop symptoms of this deadly bacteria.
The CDC released a Health Alert Network Advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk. Many hospitals have been sending out Patient Advisory Letters to warn of the potential risk of infection.
3T Stocker Heater Cooler Lawsuits
Several lawsuits have been filed against Liva Nova PLC (formerly Sorin Group Deutschland GmbH) on behalf of individuals diagnosed with M. Chimaera after having open-heart surgery. These lawsuits allege that the Stockert 3T heater-cooler device was designed and manufactured with defects that were recognized as a potential source of infection as early as 2002.
Furthermore, the 3T Stockert heater-cooler lawsuits allege that even though Liva Nova PLC knew or should have known of these defects, they failed to warn patients and medical providers of the risk. In fact, there have been 15 versions of the “instructions for use” (IFU) sent to medical professionals with the Stockert 3T heater-cooler device and none of them have a validated cleaning and disinfection procedure.