Open heart surgery infection has been recently reported in conjunction with the Sorin 3T Heater Cooler System, with patients reportedly developing deadly infections of nontuberculous mycobacteria.

The mycobacterium chimaera has been reportedly found in several open heart surgery infection cases in which the Sorin 3T Heater-Cooler device was used. Mycobacterium chimaera bacterium is typically found in soil or water. It is usually not a threat to healthy persons, but it can be potentially deadly when coming into contact with patients of open heart surgery.

This bacterium is potentially fatal in these cases, with infections potentially not responding to antibiotic treatment. This makes the potential infection especially dangerous for patients with weak immune systems or who have underwent recent cardiopulmonary surgery.

The Sorin 3T Heater Coolers was implicated in these infections in June 2016, when the FDA reported the open heart surgery infection cases in conjunction with use of this surgical device.

Previously, the FDA did not specifically state which cardiac heater cooler was suspected, but it did warn the public that 32 Medical Device Reports were submitted in conjunction with this concern.

The FDA first warned against potential open heart surgery infection in October 2015, stating the open heart surgery infection cases may be linked to cardiac heater coolers blowing bacterial cells into the surgical site.

The most recent FDA warning came on Oct. 13, 2016, when the agency provided hospitals and other medical institutions with recommendations on how to prevent infection.

Overview of Sorin 3T Cardiac Heater Cooler Problems

The Sorin 3T Heater Cooler System is manufactured by LivaNova PLC. It is used to help control the patient’s body temperature during surgical procedures. This device consists of two tanks filled with temperature controlled water, which does not make direct contact with the patient.

However, the water may aerosolize and get released into the air, where it can then be blown onto the surgical site. In 2014, the M. chimaera bacterium was discovered in the manufacturing plant in Germany where Sorin 3T heater-coolers are made.

The contamination was reportedly resolved in July 2015 when the facility was tested again. The FDA says no open heart surgery infection cases have been linked to 3T heater cooler device manufactured after September 2014.

Heater-cooler devices are used in approximately 250,000 open heart surgeries per year, with about 60% of these medical devices linked to the M. chimaera bacterial infection. The FDA also warned that open heart surgery infection may take months to years to develop, so the patients should be monitored closely during recovery.

Open heart surgery infection cases have been confirmed in multiple cases in Iowa, Michigan, and Pennsylvania from 2011 to present. According to the CDC, there have been a total of 28 confirmed heart surgery infections and the FDA stating 12 patients have died from open heart surgery infection.

Patients who recently underwent heart surgery with the Sorin 3T Cardiac Heater Cooler, should be wary of any signs of infection including:

• Night Sweats
• Muscle Aches
• Joint Pain
• Weight Loss
• Fatigue
• Unexplained Fever

Patients who developed open heart surgery infection may be able to file legal action to seek compensation.