M. Chimaera Infections
The Sorin 3T Heater-Cooler Unit and Non-Tuberculous Mycobacteria (NTM), m. Chimaera Infections
The Sorin Stockert 3T Heater-Cooler Unit™ is used during surgical procedures, including cardio-thoracic surgeries. In fact, it is estimated that as of 2015, the device was used in 65% of all hospitals in the nation. However, this device can harbor dangerous, mycobacterium Chimaera (m. Chimaera) and then aerosolize it, exposing vulnerable patients to Non-Tuberculous Mycobacteria (NTM) infections.
Between 2010 and 2016, the Food and Drug Administration (FDA) received 91 adverse event reports involving The Sorin Stockert 3T Heater-Cooler Unit™. Of the adverse event reports, 79 were related to NTM infections and 12 resulted in death. Since then, the number of complaints has grown.
The Sorin Stockert 3T Heater-Cooler Unit™ and Its Dangers
The 3T Heater-Cooler Unit™ is used during surgeries to regulate the patient’s temperature while causing cardioplegia, the temporary stoppage of cardiac activity. The device contains water tanks, each vulnerable to harboring m. Chimaera. Many surgical patients have been exposed to m. Chimaera during cardiothoracic surgeries and the implant of a prosthetic. Use of the device during the surgery increases the chances a patient may become infected.
There is significant evidence that the manufacturer of the device knew the units could host m. Chimaera bacteria. In fact, the manufacturer was notified of this danger prior to when it notified hospitals.
In 2015, the Food & Drug Administration issued a ban on any of the Sorin Stockert 3T Heater-Cooler Units entering the United States, unless it was accompanied with a certificate of medical necessity.
Disseminated Non-Tuberculous Mycobacteria (NTM), “m. Chimaera”
M. Chimaera is a non-tuberculosis mycobacteria (NTM) that can cause life-threatening infections. Unlike many other hospital-related infections, NTM infections are atypical in their incubation times. NTM infections can take months, or even years, to present symptoms in a patient. Due to the potentially lengthy dormant phase and the other recovery symptoms of surgery, these infections can be extremely difficult to detect and treat. Unfortunately, the mortality rate for disseminated m. Chimaera infections is 50%.
Atlee Hall and Claims Involving Non-Tuberculous Mycobacteria (NTM), “M. Chimaera”
In 2015, Atlee Hall first became aware of these infections and the Sorin Stockert 3T Heater-Cooler Unit™ after three local hospitals notified patients that underwent open-surgery that they may have been exposed to the mycobacteria. After being contacted by patients of Penn Presbyterian Hospital, Wellspan York Hospital, and Hershey Medical Center, our team initiated a working group to understand the complex infection and its relationship with the device. We have retained work-renowned experts in the field. Since 2015, we have continued to fight for justice for clients who have been diagnosed with a confirmed m. Chimaera infection.
Holding Negligent Parties Accountable
Since the outbreaks in Pennsylvania, Atlee Hall has been contacted by patients across the country suffering from disseminated NTM infections. Recently, there has been publicity about some settlements reached between LivaNova, the manufacturer of the Sorin Stockert 3T Heater-Cooler Unit™, and a large group of patients. However, there are more patients suffering from these dangerous infections and these patients need help.
Atlee Hall is dedicated to continuing to seek justice for our clients and anyone else that is suffering from these preventable infections.
Atlee Hall has fought for consumer and patient safety for nearly 40 years. It is our mission to hold negligent manufacturers and medical providers accountable for their actions to make our communities safer.
Resources on NTM “m. Chimaera” Infections
Related Atlee Hall Articles
- CDC Confirms Serious Danger Present in Heater-Cooler Devices Used During Heart Surgeries at Local Hospitals
- Third Pennsylvania Hospital Alerts Open-Heart Surgery Patients to Possible NTM Bacteria Exposure
- Manufacturers, Hospitals, and FDA at Fault for Failing to Alert Public of Medical Device’s Risks