Mycobacterium Chimaera Infection Lawsuits From 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 in recent years may have released a contaminated mist into the air of the operating room.
Many severe and life-threatening bacterial infections experienced months or even years after heart surgery may have been caused by a 3T Heater-Cooler Systems .
As a result of heart surgery heater-cooler bacterial contamination, 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
All cases are pursued by the M. chimaera infection lawyers at Saiontz & Kirk, P.A. on a contingency fee basis, which means that there are no out-of-pocket costs to review whether you or your family may have a case, and we receive no attorney fees unless a recovery is obtained. Request a free consultation and case evaluation.
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. provide free consultations and case evaluations for those diagnosed with M. Chimaera infections, or Nontuberculous Mycobacteria (NTM) infections, to help determine whether a 3T Heater-Cooler System may have been used during an open heart surgery.
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.
3T Heater-Cooler Heart Surgery Infection Lawsuits
The open heart surgery attorneys at Saiontz & Kirk, P.A. are reviewing potential lawsuits nationwide for heart surgery patients who have been diagnosed with a M. chimaera infection. These infections can result in the need for additional surgery, long-term antibiotic treatment, permanent injury and death.
In many cases, patients may be unaware that this device was used during heart surgery, and it may have taken more than a year and a half for symptoms of the infection to manifest, so it may be unclear that the infection was linked to the surgical procedure.
If you, a loved one or family member has suffered a M. chimaera infection following open heart surgery, request a free consultation and claim evaluation. All claims are handled on a contingency fee basis, and there are never any out-of-pocket expenses and our attorneys are paid no fees unless a recovery is obtained.
No Fees or Expenses Unless You Receive a Heart Infection Settlement
Saiontz & Kirk, P.A. is a nationally known injury law firm that is focused exclusively on representing individuals, we do not represent corporations or insurance companies.
Over the course of more than 40 years, our personal injury lawyers have collected more than $1 billion in compensation for our clients in cases of medical malpractice, automobile accidents, product liability and other personal injury lawsuits.
All 3T Heater-Cooler lawsuits will be handled by our attorneys on a contingency fee basis, which means that there are never any out-of-pocket expenses to hire our law firm and we only receive a fee if compensation is secured for our client.
Protect your family and find out if you or a loved one may be eligible for a heart infection settlement. Request a free consultation and case evaluation.