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Reports of serious nontuberculous mycobacterium (NTM) infections following heart bypass and other surgical procedures may be linked to the use of the Sorin 3T Heater-Cooler system.
Many of these surgical devices may release contaminants into the sterile air of the operating room, resulting in hard-to-treat and life-threatening infections like M. chimeara and M. abscessus.
STATUS OF 3T HEATER-COOLER LAWSUIT: Product liability lawyers are reviewing potential 3T Heater-Cooler surgical infection lawsuits for individuals who may have contracted an infection after the systems were used to regulate their body temperature during a surgical procedure.
MANUFACTURER: Sorin Group, also known as Livanova PLC.
OVERVIEW: The 3T Heater-Cooler System, sometimes referred to as the Sorin 3T or Stockert 3T Heater-Cooler System, use tanks of temperature-controlled water to regulate blood temperature during surgical procedures. They appear to most commonly be used with heart bypass surgeries, but have also been used during liver transplants and other major operations.
According to the U.S. Centers for Disease Control and Prevention (CDC), the devices are used in about 60% of all heart bypass surgeries in the United States. However, federal regulators have discovered that certain cardiac heater-cooler devices manufactured before September 2014 may have become contaminated with nontuberculous mycobacterium (NTM).
Following reports of M. chimeara infections and other types of NTM infections among individuals exposed to the 3T Heater-Cooler System, the FDA has warned that contaminants in the water tanks or lines may be released as vapor through an exhaust fan, entering the sterile surgical site and open chest cavity of patients.
A study published in June 2017 warned that as many as one-in-three 3T systems may be contaminated.
On October 18, 2018, Livanova, the manufacturer, issued a medical device correction notice instructing health care professionals how to ensure the right amount of hydrogen peroxide was in the system to kill microbial contaminants. The company also announced it was making changes to the system to prevent water droplets and aerosol from the devices from contaminating the operating room.
3T HEATER-COOLER INFECTION PROBLEMS: The first reports of 3T system infections came to the FDA’s attention in 2010, and were believed linked in general to heater-cooler systems. However, in 2014, M. chimeara was found in the production line and water supply at a European 3T Heater-Cooler System production facility.
In July 2015, the manufacturer issued a corrective action and gave healthcare professionals new cleaning instructions and advice on how to determine if the systems were contaminated, which was later classified as a 3T Heater-Cooler system recall by the FDA.
The FDA issued a safety communication on heater-cooler units of all brands in October 2015, and issued a warning letter to Sorin in December 2015, following inspections which found serious violations at facilities in Arvada, Colorado, and Munchen, Germany.
In June 2016, the FDA issued another infection warning, indicating that the infections it had been seeing were specifically linked to the Sorin 3T Heater-Cooler system. This warning was updated in October 2016, when the agency warned doctors not to use the systems if they were manufactured before September 2014 unless it was a life-or-death situation and no other system was available.
NTM INFECTION RISKS: Nontuberculous mycobacterium (NTM) infections can cause severe and potentially fatal illnesses. They can be difficult to detect, may lie dormant for months before symptoms show, and by that time the infection could have spread to significant parts of the body, making it hard to treat and rid the patient of the infection.
Patients must often go through long, harsh, antibiotic therapy, wound debridement, blood transfusions and may often need repeated surgeries to clear the body of the infection, and in some cases the infections still are not completely removed and return again at a later date.
Symptoms can include:
- Abdominal pain or pain at the surgical site
- Redness or puss at the surgical site
- Inflammation of organs
FIND OUT IF YOU MAY QUALIFY FOR A 3T HEATER-COOLER SURGERY INFECTION LAWSUIT: Free consultations and claim evaluations are provided by surgical infection lawyers for individuals throughout the United States for individuals diagnosed with an NTM infection following surgery involving the 3T Heater-Cooler system.
All 3T Heater Cooler infection lawsuits were consolidated in February 2018 before one judge in a Pennsylvania federal court for pretrial proceedings.
In late March 2019, Livanova announced it had reached a $225 million settlement agreement to resolve most heart surgery infection lawsuits.