The FDA has warned healthcare professionals, including cardiothoracic surgeons, of the risk of Mycobacterium chimaera infections associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems (3T), used during open-heart surgery (FDA Safety Communication). In response to the M. chimaera findings in August 2014 (see below), the manufacturer added cleaning and disinfection procedures to the production line in September 2014. To date, the FDA is not aware of patient infections in the United States associated with 3T devices that were manufactured after September 2014.
Mycobacterium Lawsuit Compensation
If your loved one has been diagnosed with a Mycobacterium chimaera infection, contact our law firm about a lawsuit for compensation. Request a free consultation with one of our lead lawyers Fred Pritzker or David Szerlag.
If a patient contracts an infection from Mycobacterium chimaera, that patient could get pneumonia, a severe infection of the lungs, and sepsis, a condition sometimes referred to as a blood poisoning that can cause tissue damage and organ failure. Both pneumonia and sepsis cause death.
A Mycobacterium chimaera lawsuit should seek money damages for
- medical expenses
- lost income (time off of work or job loss, for example)
- pain and suffering
- other damages determined by your lawyer.
These cases are complicated by the fact that Mycobacterium chimaera infections are hard to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure. Fred and his team of lawyers, the Bad Bug Law Team®, have years of experience with infectious disease lawsuits, including cases where the source of an illness is not immediately apparent. They have won millions for their clients, including a recent $7.55 million verdict for a young child who contracted an E. coli infection.
Mycobacterium Chimaera Found in Facility That Makes 3T Heating-Cooling Device
In testing conducted by the manufacturer in August 2014, Mycobacterium chimaera contamination was found at the facility in Germany where the Stӧckert 3T Heater-Cooler System is manufactured (Perkins):
- on the production line
- in the water supply.
Some of the units that were manufactured at this facility were distributed in the United States.
In response to the Mycobacterium 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 in June 2015 did not show M. chimaera on the production line, potentially eliminating the production line as a contamination source,” according to the FDA. The FDA also stated, “To date, the FDA is not aware of M. chimaera patient infections associated with 3T devices that were manufactured after September 2014″ (FDA Safety Communication).
The FDA is requesting health care facilities to take additional steps to help mitigate the risk of infection from Mycobacterium chimaera bacteria associated with the use of the 3T.
The Stӧckert 3T Heater-Cooler System (3T), manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), is used by hospitals to provide temperature-controlled water to 1) oxygenator heat exchangers, 2) cardioplegia (paralysis of the heart) heat exchangers, and/or 3) warming/cooling blankets to warm or cool a patient during cardiopulmonary bypass procedures lasting six hours or less. Tanks are used to provide temperature-controlled water, which is circulated 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 (get into the air via contaminated water mist). Studies have found that contaminated water mist from heater-cooler systems can transmit bacteria through the air and through the device’s exhaust vent into the environment and to the patient.
In a recent study published in Emerging Infectious Diseases, a CDC publication, researchers conducted experiments to determine how heater-cooler units could transmit Mycobacterium chimaera bacteria.
“Smoke dispersal experiments demonstrated that air originating from the heater–cooler unit was propelled by the ventilator of the unit to merge with the ultraclean airflow near the ceiling and ultimately reached the surgical field. This finding was corroborated by particle measurements in the same setup and showed increased particle counts in the surgical field when the heater–cooler unit airflow was oriented toward the operating table than at baseline and when the opposite heater–cooler unit orientation was used. Furthermore, we demonstrated that viable M. chimaera can be recovered on sedimentation plates placed in the air outflow path at a distance of up to 5 m from a contaminated heater–cooler unit. These results corroborate and extend previous observations” . . . .
“Smoke dispersal experiments visualize the airflow pathway by which bacterial aerosols can access the surgical field, and particle count experiments showed a major increase in contamination of air reaching the surgical field” (Sommerstein).
How Has The CDC and FDA Associated the 3T with Mycobacterium Chimaera in the United States?
As stated above, testing conducted by the manufacturer of the 3T in August 2014 found Mycobacterium chimaera contamination on the production line and water supply at the 3T manufacturing facility. Some of the 3T devices manufactured at this facility were distributed in the United States.
In response to the M. chimaera findings in August 2014, the manufacturer added cleaning and disinfection procedures to the production line in September 2014. To date, the FDA is not aware of patient infections in the United States associated with 3T devices that were manufactured after September 2014.
The Centers for Disease Control and Prevention (CDC) in conjunction with National Jewish Health performed whole-genome sequencing on clinical isolates from the following:
- 11 infected patients;
- samples taken from inside of 5 3T devices (manufactured before September 2014) from hospitals in Pennsylvania and Iowa where there were clusters of patient infections with Mycobacterium chimaera;
- samples of the water drained from the 3T devices; and
- air samples collected while the devices were in operation.
The results obtained “strongly suggest that the tested 3T devices had a common source of Mycobacterium chimaera contamination,” according to FDA:
“These results strongly suggest a point-source contamination of Stöckert 3T heater-cooler devices with M. chimaera. 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”. . . .
“Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger. Over 250,000 procedures using cardiopulmonary bypass are performed in the United States each year. Stöckert 3T heater-cooler devices represent approximately 60% of the U.S. market “ (Perkins).
What To Do If You Have Had Open-Heart Surgery?
If you have undergone cardiopulmonary bypass, be aware of the possible signs and symptoms of a Mycobacterium chimaera infection, which may include:
- fatigue
- fever
- pain
- redness, heat, or pus at the surgical site
- muscle pain
- joint pain
- night sweats
- weight loss
- abdominal pain
- nausea
- vomiting.
If you have undergone a cardiopulmonary bypass procedure and are experiencing any of these signs and symptoms, contact your doctor immediately. If you are not currently experiencing any changes in your general health, ask your doctor if you need to be tested or need monitoring.
Sources
- FDA Safety Communication. October 13, 2016. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm520191.htm
- Sommerstein R, Rüegg C, Kohler P, et al. Transmission of Mycobacterium chimaera from Heater–Cooler Units during Cardiac Surgery despite an Ultraclean Air Ventilation System. Emerging Infectious Diseases. 2016;22(6):1008-1013. doi:10.3201/eid2206.160045.
- 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. DOI: http://dx.doi.org/10.15585/mmwr.mm6540a6