Mycobacterium Chimaera Infection Lawsuits for 3T Heater-Coolers
Heater-cooler devices are commonly used during heart surgery to control blood temperature during the procedure. However, certain devices distributed to hospitals nationwide prior to 2016 may have released a contaminated mist into the air of the operating room.
As a result of problems with 3T Heater-Cooler Systems, individuals were 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 3T Heater-Cooler. The contents of this page are provided for informational purposes to outline the background and allegations for claims previously pursued.
3T 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.
The FDA indicates that problems with one device in particular, the Sorin/Stockert 3T Heater-Cooler System, may be the cause of a number of severe infections experienced in recent years. In many cases, these heart surgery infections did not surface until long after the procedure.
Following reports of Mycobacterium Chimaera infections among cardiac surgery patients, investigators determined that certain 3T Heater-Cooler Systems manufactured prior to September 2014 may have become contaminated.
The CDC estimates that the devices may have been used in about 60% of the 250,000 heart bypass procedures performed each year in the United States.
As the heater-cooler system circulates water through tubes into a heat exchanger, where blood is pumped into separate chambers during heart surgery, a contaminated vapor may be released into the air through an exhaust fan. When the device is placed in the operating room, this contaminated vapor may enter the sterile surgical field and cause an infection.
M. Chimaera Infection Risk
Mycobacterium Chimaera, more commonly known as M. Chimaera, is a subspecies of nontuberculous mycobacterium (NTM), which occurs naturally in the environment.
While this 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.
It is often difficult to identify potential heart surgery infection lawsuits, as symptoms may not develop for months or years after initial exposure. Therefore, individuals and families may not immediately understand the link between an M. Chimaera and heart surgery.
The lawyers at Saiontz & Kirk, P.A. previously reviewed potential claims for individuals diagnosed with M. Chimaera infections, or Nontuberculous Mycobacteria (NTM) infections, to help pursue damages against the manufacturer of certain 3T Heater-Cooler Systems used during an open heart surgery. New cases are no longer being accepted.
Timeline 3T-Heater Cooler Problems
FDA receives first report of M. chimaera infections linked to open-heart surgery heater-cooler systems.
M. chimeara found in the production line and water supply at the 3T manufacturing facility.
The manufacturer issues a “corrective action” for the 3T system, with new cleaning instructions and instructions on how to determine whether it is contaminated. The FDA later determines this to be a 3T Heater-Cooler recall.
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 the 3T system, after finding serious violations at facilities in Munchen, Germany, and Arvada, Colorado. The agency issues an import alert restricting the availability of 3T devices to healthcare facilities where its use is determined to be medically necessary.
European study of an M. chimeara infection outbreak in Germany links all of the cases to the 3T Heater-Cooler system.
The FDA warns that the 3T heater-Cooler System appears to be linked to infections. Days later, FDA scientists and experts weighed in on contamination concerns related to all heater-cooler systems at an FDA advisory board hearing.
The FDA updates its 3T System warning and provides recommendations to doctors and patients, calling on doctors not to use any 3T system manufactured before September 2014 unless it is a life-or-death situation and no other system is available.
Updated cleaning instructions and design changes announced to address cardiac surgery infection risks from 3T Heater-Coolers.
Heart surgery infection settlements reached by the manufacturer of 3T Heater-Cooler Systems to resolve lawsuits pending nationwide.
3T Heater-Cooler Heart Surgery Infection Lawsuits
The open heart surgery attorneys at Saiontz & Kirk, P.A. are no longer reviewing additional lawsuits for heart surgery patients who have been diagnosed with a M. chimaera infection.
On March 29, 2019, Livanova announced that it had reached an agreement to resolve about 75% of the pending cases filed nationwide in recent years. The settlement involves a total payment of up to $225 million, with $135 million paid no earlier than July 2019, and the rest paid in January 2020.