A number of open heart surgery patients have been shown to have developed severe infections from the non-tuberculous mycobacteria, Mycobacterium chimaera (or M. Chimera). The infection has been shown to be potentially life threatening and has been linked to issues with the 3T Heater-Cooler systems used in operating rooms.
Problematic Heater-Cooler systems
Various machines are used to control the conditions of a patient’s body while they are under general anesthesia during surgery. This helps to improve their medical condition and the outcome of their surgeries. One such machine is a heater-cooler unit. These units are used to control the body temperature of patients during surgery.
The devices include a water tank that supplies water at a specified temperature to blankets or heat exchangers. This provides heating or cooling to the body.
Research on 3T systems have shown that the water used in the system can be contaminated and result in the release of bacteria through the system’s exhaust vents. When these bacteria come into contact with patients, they cause infections.
The Journal of Clinical Microbiology published a case report in 2013 detailing two cases in which heart surgery patients developed infections caused by M. chimera. No connection was made to the 3T systems that were used at the time. However, when the bacteria were discovered in the water supply and production line of the manufacturing facility, the connection became clear.
A more recent study published in June 2016, reported ten cases of heart surgery patients that had developed M. Chimera infections. The Food and Drug Administration (FDA) issued a safety communication in the same month. The warning cited the risk of developing M. chimera infections when 3T heater-cooler systems were used in open heart surgeries.
Hospitals have since been required to take steps to remove the heater-cooler devices, connectors and tubing that tests positive for the bacteria. They are also required to monitor patients who have undergone surgery for signs of infection. These include:
- Infection at the surgical site
- Bacteremia
- Hepatitis
- Abscess
- Osteomyelitis
- Endocarditis
- Renal insufficiency
3T Heater-Cooler Lawsuits and M. Chimera Infections
Patients and loved ones are now filing claims against the manufacturers of the 3T system, LIvaNova PLC. This is because the device has been directly linked to the transmission of bacteria to patients during surgery.
The challenge in filing the claims is that many of the symptoms of the infections take several months and even years to develop. Some patients who had been exposed have also died as a result of the complications.
Be sure to talk to an experienced medical device attorney if you or someone you know has experienced heart surgery and subsequently suffered an M. Chimera infection.
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