Contact our law firm if you got a Mycobacterium chimaera infection after surgery get compensation. Contact our law firm if you:
- have been diagnosed with a M. chimaera infection;
- have a loved one who died (wrongful death) from an infection after open heart surgery;
- have received a letter telling you that you were potentially exposed to infection-causing pathogens after a surgery.
In July 2015, a Pennsylvania hospital identified a cluster of invasive nontuberculous mycobacterial infections among open-heart surgery patients. An investigation by the Pennsylvania Department of Health, with assistance from CDC, “used both epidemiologic and laboratory evidence to identify an association between invasive M. avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices, all manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH)” (Perkins, CDC).
Health officials used whole genome sequencing (WGS) to obtain detailed DNA “fingerprints” of the Micobacterium chimaera isolates taken from open-heart surgery patients and the Stöckert 3T heater-cooler devices. Samples from heater-cooler devices included swabs from the following:
- the interior of the device
- water drained from the devices
- air samples collected while a device was operating.
The DNA fingerprints from the patients and the devices were similar enough to “strongly suggest a point-source contamination of Stöckert 3T heater-cooler devices with M. chimaera” (Perkins).
This pathogen as also found in the plant in Germany where these devices are made:
“A recent report from Germany noted that preliminary typing results of M. chimaera from heater-cooler devices from three different European countries were almost identical to samples obtained from the manufacturing site, further supporting the likelihood of point-source contamination” (Perkins).
“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” (FDA, Update).
The Stöckert 3T Heater-Cooler System is manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH). It is used during cardiothoracic (open-heart) surgeries to warm or cool a patient in an effort to improve patient outcomes. These devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. The FDA has warned that, “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 Warns Hospitals, Surgeons and Patients
On June 1, 2016, the FDA issued “Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stöckert 3T Heater-Cooler System – Safety Communication” to provide information and recommendations infections associated with the use of the Stöckert 3T Heater-Cooler System in patients who had cardiothoracic (open heart) surgeries.
On October 13, 2016, the FDA updated its June 1, 2016 Safety Communication to provide new information, specifically, that the FDA had received reports of patients in distinct geographic regions within the U.S. being infected after undergoing cardiothoracic surgery that involved the use of the 3T. (See discussion of this above.)
According to the FDA, a potential root cause of infection from the heater-cooler devices includes transmission of bacteria through the air (aerosolization). There is the potential for this pathogen to grow in a water tank in the heater-cooler units. Although the water in the heater-cooler unit does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit this dangerous pathogen through a vent or other small opening between the inside and outside of the device’s water tanks into the operating room environment and the patient’s open surgical cavity. Water in the tanks is agitated, making it bubble, which may increase the potential for aerosolization of bacteria. Studies have found that mycobacteria are found in much higher concentrations on water droplets ejected into the air from air bubbles rising and bursting in the tank as compared to the concentration of mycobacteria found in the water.
What is Mycobacterium Chimaera?
Mycobacterium chimaera is a type of nontuberculous mycobacterium (NTM) classified as a slow grower. This pathogen may cause serious illness or death. It can take years for someone infected to become sick. Symptoms may include:
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
If you have undergone heart surgery and are experiencing any of the signs and symptoms, contact your health care provider as soon as possible. If you are diagnosed with this infection, you or a family member can contact our law firm for a free case evaluation. Find out if you have a lawsuit against a hospital or a medical product company.
FDA. “UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication.” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm520191.htm
Perkins KM, Lawsin A, Hasan NA, et al. Notes from the Field. Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery United States. MMWR Morb Mortal Wkly Rep 2016;65:1117–1118.
FDA. “FDA’s Ongoing Investigation of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices.” http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm