Mycobacterium Chimaera Infection Lawsuits
Heater-cooler devices are commonly used during heart surgery to control blood temperature during the procedure. However, certain devices may release a contaminated mist into the air of the operating room if proper cleaning instructions are not followed, or potentially contaminated systems distributed prior to 2016 were not removed by hospitals.
If proper standards of care were not followed, individuals may have been exposed to an increased risk of M. Chimaera infections, which is a slow growing type of nontuberculous mycobacterium (NTM). Long after heart surgery, the infection may cause symptoms like:
- Fatigue, Fever, Pain
- Redness, Heat or Pus at Surgical Site
- Abdominal Pain, Nausea, Vomiting
- Post-Surgery Infection Treatment
- Wrongful Death
The lawyers at Saiontz & Kirk, P.A. are no longer reviewing new heart surgery infection lawsuits against the manufacturer of the Sorin 3T Heater-Cooler. The content of this page describe the potential for surgical malpractice cases or claims against other entities.
Heater-Cooler Infection Problems
Heater-cooler devices are commonly used during heart surgery, involving tanks that provide temperature-controlled water to control blood temperature during the procedure.
In October 2015, the FDA issued a safety communication about the risk of nontubercilous mycobacterium infections from all heater-cooler devices, providing critical information for surgeons, hospitals, operating room managers and other health care providers who use heater-cooler devices.
The heater-cooler devices share common design elements, which provide heated or cooled water to (a) oxygenator heat exchangers; (b) cardioplegia (paralysis of the heart) heat exchangers and/or (c) warming/cooling blankets used during open heart surgery.
The FDA now warns that there is a potential for NTM and other organisms to grow in the water tanks for any heater-cooler device. This may aerosolize into the operating room during surgery, posing a serious health risks for patients undergoing open-chest surgical procedures.
Recommendations have been provided to hospitals and medical providers for years about steps that must be taken to reduce the risk of infection, including:
- Strict adherence to cleaning and disinfection instructions provided by the manufacturer, including the importance of following updated instruction provided since 2015;
- Do not use tap water to rinse, fill or refill heater-cooler water tanks, which may introduce NTM bacteria;
- Heater-Cooler exhaust vents must be directed or channeled outside the operating room or away from the surgical field;
- Remove heater-cooler devices that show any sign of discoloration or cloudiness in the fluid lines/circuits
- Conduct regular cleaning, disinfection and maintenence of heater-cooler devices.
M. Chimaera Infection Risk
The most common heart surgery infection problems linked to heater-coolers involve Mycobacterium Chimaera, more commonly known as M. Chimaera. This is a subspecies of nontuberculous mycobacterium (NTM), which occurs naturally in the environment and may be introduced through water that is not passed through a filter of less than or equal to 0.22 microns.
While Nontuberculous Mycobacteria (NTM) typically does not pose a risk, during open heart surgery organs and the chest cavity may be directly exposed to the bacteria, potentially causing severe and potentially fatal infections. In most cases, the infection may develop months or even years after exposure, making it difficult for individuals and families to recognize that they may have a potential heart surgery infection case.
The lawyers at Saiontz & Kirk, P.A. previously reviewed claims against the manufacturer of certain specific heater-coolers that were the subject of a separate FDA Safety Communication issued in October 2018. While new claims are no longer being pursued against the maker of this product, individuals may be entitled to financial compensation through a medical malpractice lawsuit or product liability lawsuit against manufacturers of other devices.
Timeline Heater Cooler Problems
FDA receives first report of M. chimaera infections linked to open-heart surgery heater-cooler systems.
The FDA issues a safety communication warning about the potential risk of infections involving heater-cooler units of all types used during open heart surgery.
The FDA issues a warning letter to the manufacturer of one specific system, after finding serious violations at manufacturing facilities.
European study of an M. chimeara infection outbreak in Germany links cases to the use of heater-cooler systems.
A report in the CDC Morbidity and Mortality Weekly Report (MMWR) describes notes from the field involving Mycobaterium chimaera contamination of heater-cooler devices used during cardiac surgery.
Updated cleaning instructions and design changes announced to address cardiac surgery infection risks from certain Heater-Coolers.
Heater-Cooler Infection Lawsuits
The open heart surgery attorneys at Saiontz & Kirk, P.A. are no longer reviewing additional lawsuits against the manufacturers of certain devices, but individuals diagnosed with M. chimaera infections may be entitled to financial compensation from hospitals or medical providers that failed to follow the proper standard of care to reduce the risks associated with these devices.