Heater cooler infections have been reported across the United States, from patients who underwent surgery using the Sorin 3T Heater Cooler System. These devices have been allegedly linked to heater cooler infections, which can be potentially deadly and appear months after surgery.

This infection is described as potentially fatal and ‘blood eating’. The infection has reportedly impacted thousands of British patients and killed seven people in the last year.

The Sorin 3T Heater Cooler System is a temperature control device to help patients control their body temperature during bypass surgeries.

The device consists of two temperature controlled water tanks that do not touch the patient, but the FDA warned “there is potential for contaminated water to enter other parts of the device and aerosolize.” This means the bacteria can enter the air and make direct contact with the patient.

These devices were reportedly contaminated during the manufacturing process from a LivaNova plant in Germany. The contamination was discovered in 2014. While the contamination was reportedly resolved, devices manufactured before 2014 may present the risk of heater cooler infections.

Overview Heater Cooler Infections

These heater cooler infections were first linked to the Sorin 3T Heater Cooler System in June 2016, when the FDA stated potentially deadly mycobacterium chimaera (M. chimaera) infections were linked to the devices made by LivaNova.

The FDA first warned the public about this link in October 2015, when it had received 32 Medical Device Reports (MDR) regarding heater cooler infections. While the M. chimaera infection is rare, this bacteria can quickly turn fatal due to the speed at which it can progress.

These heater cooler infections have also been reported in other countries, with a recent report from the Daily Mail indicating the problem is still apparent in the medical community. According to the report, 17 patients are currently fighting heater cooler infections allegedly caused by the Sorin 3T devices.

The total number of recognized cases of these heater cooler infections increased from 26 cases in January 2017 to 39 cases several months later in November. According to Public Health England (PHE), most of the deaths have been adults. However, one young child died as a result of a heater cooler infection.

PHE representatives say that treating this infection is difficult, and fear there could be many more deaths. Even with national warnings released, it is reported that many doctors in the United Kingdom have not received information on how to recognize the infection or provide treatment.

Patients who are struck with these heater cooler infections often sustain extended hospital stays, endure severe antibiotic treatment, deafness, and possible multiple organ failure. Public health advocates are calling for updates about heater cooler infections, writing to Public Health England and NHS England for a status update.

There have been an unknown number of deaths reported in Europe, Australia, and the United States as well. European health officials have issued warnings to the medical community in 2012. However Public Health England had opted to not warn the public, leading to public outcry.

Some hospitals have taken to updating their cleaning and disinfection procedures to help reduce the risk of infection, and replaced all the cardiac heater coolers with updated models.

The last warning the United States received regarding the cardiac heater cooler infections was released on Oct. 13, 2016, which provided health officials in America recommended procedures to prevent the spread of infection.