The Sorin 3T Heater-Cooler System, used during various types of heart and lung surgeries, can spread a dangerous bacteria during the procedures causing serious infections, illnesses, and even death. Lawsuits are currently being filed as a result of the infections caused by these products. The number of lawsuits claiming LivaNova’s Sorin 3T Heater-Cooler systems caused injuries have more than doubled in the last two years. Now, a federal panel has decided that the cases will be transferred to a single federal court in order to move them more quickly through the legal process. Our firm is currently representing individuals who have suffered infections as a result of the Stockert 3T Heater-Cooler System. Click here to view the sample patient notification letter, sent from hospitals to their potentially infected patients.
A heater-cooler unit is a machine used in most open-heart and open-chest bypass surgeries to regulate the patient’s body temperature during surgery, preventing them from becoming too warm or too cold. These devices are important for use in heart and lung (cardiothoracic) surgeries because they generally involve the intentional and temporary stopping of the patient’s heart and/or lung functions.
The most widely used model of heater-cooler system is the Stockert 3T made by LivaNova (the company formed by the merging of Sorin and Cyberonics, Inc. in June 2015), which was recently linked to the spread of a bacteria called Nontuberculous Mycobacteria (“NTM”). NTM has been known to cause serious illnesses, including chronic lung infections in immunocompromised patients and can even result in death when left untreated. The Stockert 3T heater-cooler unit is used in approximately 60% of the 250,000 surgeries performed in the U.S. each year requiring the use of a heater-cooler unit. The most common procedures in which a heater-cooler unit is used include:
A heater-cooler device includes a water tank with a compartment inside that separates warm and cold water, as well as a heating and cooling unit that allows for air to flow in and air to flow out. The devices provide temperature-controlled water to an external heat exchanger or to warming/cooling blankets through closed water circuits that are sealed off to prevent contact with open air.
Although the water in the closed circuits never comes into direct contact with the patient, there is always the potential for contaminated water to enter other parts of the device or transmit bacteria through the air via the device’s exhaust vent into the environment and the patient. Heater-cooler devices play a few different roles in surgery:
Use of the Sorin 3T Heater-Cooler system has been linked to serious infections, most notably Nontuberculous Mycobacteria (“NTM”) infection. If you or a loved one underwent any operation in which a heater-cooler unit was used and have experienced any of the following symptoms or complications:
Treatment for these complications can persist for months and even years, and if left untreated patients with NTM infections are at risk of death.
In 2010, the U.S. Food and Drug Administration (“FDA”) began to receive reports that patients were developing serious infections during cardiothoracic surgeries. By 2015, the FDA, through hospital surveys and research, determined that heater-cooler devices were responsible for the issues and by 2016, they were able to link the growing number of infections to the Stockert 3T specifically.
In June 2015, Sorin, by then known as LivaNova, recalled the Stockert 3T Heater-Cooler devices due to these infections which were officially linked to the devices by the FDA. The recall stated that the infection potential is greater if device disinfection is neglected and maintenance is not performed per the instructions for use. It was discovered that the defective devices may have been in circulation up until 2014, with the first incident of infection reported as early as 2012.
In December 2015, the FDA issued a Warning Letter to LivaNova after inspecting two of its facilities, one in Germany and one in the U.S. The warning stated that during the FDA’s inspection of LivaNova’s German facility, investigators determined that the firm’s devices were “contaminated” in methods used for manufacturing, packaging, storing or installation and found that these practices were in violation of current Quality System regulations.
At the conclusion of the inspection, the FDA noted that as a part of the company’s recall, LivaNova issued an update to its cleaning and disinfection instructions following complaints of patient deaths due to infections caused by the Stockert 3T. But the FDA concluded that the acceptance criteria for the test did not demonstrate that the updated procedures produced a reduction in bacteria. The FDA stated that it will remain “actively engaged” in the process.
The number of lawsuits involving the Stockert 3T Heater-Cooler Unit have more than doubled in the last year. On February 1, 2018, 39 lawsuits over the heater-cooler devices were consolidated into a multi-district litigation (“MDL”) in Pennsylvania.
The lawsuits claim that the Sorin 3T spread bacteria during surgeries, causing serious infections or even patient deaths. If you or a loved one has had surgery in which a heater-cooler device was used, you may be eligible for compensation. Depending on the severity of your infection/case, you could be compensated for:
Patients in Pennsylvania who’ve undergone open heart surgery requiring a cardiopulmonary bypass at two hospitals may be infected with a deadly bacteria. Over 3,500 patients who underwent heart surgery at WellSpan York Hospital in York and Penn State Hershey Medical Center in Hershey may have been exposed to Mycobacterium chimaera, a particularly invasive bacteria.
According to federal agencies, and now as alleged in lawsuits filed against the manufacturer, a surgical unit used during heart surgeries may have spread the bacteria, Mycobacterium chimaera. This specific bacteria is a species of nontuberculous mycobacterium (“NTM”) and is particularly difficult to diagnose due to its long incubation period. Many patients with this bacterial infection get diagnosed several months or years after the original heart surgery.
At least 1,300 patients at WellSpan York Hospital and 2,300 patients at Hershey Medical Center may have been exposed to the bacteria. As early as July 2015, WellSpan York Hospital notified the Pennsylvania Department of Health (“DOH”) about a cluster of patients with bacterial infections. It’s unclear when Hershey Medical Center first notified the PA DOH. In 2015, both hospitals began notifying heart surgery patients who had surgeries between 2011 and 2015. An NTM infection is particularly invasive and often results in death. According to a May 2017 study in Emerging Infectious Diseases, Invasive Nontuberculous Mycobacterial Infections among Cardiothoracic Surgical Patients Exposed to Heater–Cooler Devices, of the 10 patients at York Hospital who were identified as having an NTM infection, 7 had died.
The Pennsylvania DOH began a field investigation in conjunction with the Centers for Disease Control to determine the source of the infections. A few months later, the CDC and the Pennsylvania DOH revealed that the bacterial infections were caused by a specific surgical device, a heater-cooler unit (“HCU”) used during the surgery to heat and cool a patient’s blood during the bypass procedure. The investigation revealed the presence of the bacteria in samples and swabs taken of the HCUs and operating room air samples while the HCU was ON but not when the HCU was OFF. The cluster of infections in York and Hershey, PA was no anomaly. In fact, heart surgery patients around the United States have been affected. These infections have been identified in patients in over 15 states, including Iowa and South Carolina.
Emerging Infectious Diseases, May 2017, Invasive Nontuberculous Mycobacterial Infections among Cardiothoracic Surgical Patients Exposed to Heater–Cooler Devices
Pennsylvania Department of Health, Winter 2016, Healthcare-Associated Infection Prevention Hospital Edition Newsletter
Pennsylvania Department of Health, Nov. 2015, Department of Health Urges Hospitals to Increase Vigilance after Nontuberculosis Mycobaterium Infections Identified in Patients at Penn State Hershey Medical Center
Pennsylvania Department of Health, Oct. 2015, Cluster of Nontuberculous Mycobacterium Infections Identified in WellSpan York Hospital Patients
Pennsylvania Department of Health, 2015, Advisory #322, PADOH and PSA Guidance Regarding Nontuberculous Mycobacterium (NTM) Infections among Patients Undergoing Open Heart Surgeries on Cardiopulmonary Bypass
Each year, about 250,000 heart bypass surgeries are performed in the U.S. The majority of cardiac and cardiopulmonary surgeries in the U.S. have been performed while using a heater-cooler unit (“HCU”), which regulates the patient’s body temperature during the procedure. In 2010, the FDA and/or CDC began receiving reports of bacterial infections after cardiac surgeries in the U.S. These government agencies later identified how the bacteria spread. During use of HCUs, the bacteria would become airborne, thus potentially invading the patient’s tissues. The infections were caused by a specific bacteria, Mycobacterium chimaera, which is a species of nontuberculous mycobacterium (“NTM”). Mycobacterium chimaera is a relatively rare bacteria. It is present in water and soil and historically seen in immunocompromised patients or those with lung disease.
In 2015, Mycobacterium chimaera infections after open heart surgery were identified and studied in Europe. This triggered increased awareness at the CDC and FDA the same year. By late 2015, the CDC and the FDA began issuing warnings about problematic bacterial infections after cardiac surgery. They involved a specific HCU, the Sorin or Stockert 3T Heater-Cooler, which was recalled by the manufacturer in 2015. Learn about Sorin/Stockert 3T Heater-Cooler lawsuits, which are currently being filed against the manufacturer.
Diagnosis of Mycobacterium chimaera bacterial infections after cardiac surgery can take months if not years. In some cases, diagnosis may not occur until up to four to six years after the surgery. Diagnosis tends to be difficult for multiple reasons:
Localized signs or diagnoses include prosthetic valve endocarditis, prosthetic vascular graft infection, sternotomy wound infection, mediastinitis or deep organ space infection. Non-localized signs include bacteremia, splenomegaly, arthritis, osteomyelitis, chorioretinitis, cerebral vasculitis, myocarditis, hepatitis, and nephritis. Patients in rural areas of the country face a greater risk for delayed diagnosis of a bacterial infection after heart surgery. The surgeon or hospital where the surgery was performed may be too far for post-op visits and treatment. Patients in these situations often follow up with their local doctors, who simply may not be aware of the risk of the Mycobacterium chimaera infections after surgery.
Discuss difficulties in diagnosis of an NTM infection. An infectious disease specialist may be necessary.
In one case, a 60 year old male underwent two heart procedures within a three year span and died shortly after the second procedure. Analysis of the patient’s medical case revealed that he had a Mycobacterium infection. About 2 years after the first surgery (aortic, mitral reconstruction with implant), the patient reported symptoms of fever, weight loss and respiratory problems. Prosthetic valve endocarditis was ruled out with negative blood cultures; even subsequent testing produced negative results. Sarcoidosis was diagnosed, and the patient was started on immunosuppressive therapy, including a steroid (prednisone). The patient’s condition deteriorated over the course of the following year. He was admitted to the hospital with respiratory distress. An echocardiogram showed mitral and aortic valve insufficiency, so he was referred for additional valve surgery. During the surgery, acute necrotizing mycobacterial endocarditis was discovered. Further testing revealed the presence of two kinds of bacteria, Mycobacterium avium and Mycobacterium chimaera, in the patient’s heart tissue and implant. He was started on a strong, toxic trio of drugs: rifabutin, ethambutol and clarithromycin/azithromycin (the current standard for treating Mycobacterium infections). Unfortunately, the patient died of heart failure two weeks later.
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Page last reviewed and updated: November 14, 2019