Heater-Cooler System Lawsuit Update

Several heater-cooler lawsuits have been filed against the device manufacturer Liva Nova PLC (formerly Sorin Group Deutschland GmbH) on behalf of individuals diagnosed with M. Chimaera after having open-heart surgery.

The lawsuit alleges that the device was designed and manufactured with defects that were recognized as a potential source of infection as early as 2002.

Furthermore, the 3T Stockert heater-cooler system lawsuit alleges that even though Liva Nova PLC knew or should have known of these defects, they failed to warn patients and medical providers of the risk.

In fact, there have been 15 versions of the “instructions for use” (IFU) sent to medical professionals with the Stockert 3T heater-cooler device and none of them have a validated cleaning and disinfection procedure.

Of the 16 heater-cooler lawsuits that have been filed in six different districts, 10 of the cases are being informally coordinated in a South Carolina federal court, and six actions are pending outside of South Carolina.

The heater-cooler lawsuits make common allegations that the plaintiffs were exposed to M. chimaera or M. abscessus, types of non-tuberculous mycobacteria (NTM) after undergoing surgery utilizing the 3T Heater-Cooler system.

While some patients do not become ill from NTM exposure, those with a weak immune system may contract a slowly progressive and destructive disease that may become chronic and require ongoing medical treatment.

The FDA and CDC are warning patients and providers about the potential risk of infection from the Stockert 3T Heater-Cooler System used during open-chest surgeries involving the heart, lung or liver.

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the United States every year.

Heater-cooler devices are an essential part of these surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure, yet most patients are not aware of the device’s usage.

For this reason, the CDC and the FDA are now warning patients who had cardiothoracic surgeries which can include the heart, liver or lung to seek medical care if they are experiencing symptoms associated with infections.

These infections could indicate they were exposed to M. Chimaera, a dangerous form of nontuberculous mycobacterium (NTM).

Heater cooler devices are used to control the temperature of patient’s blood and organs during approximately 60 percent of open heart surgeries performed in the U.S.

The system circulates water through tubes into a heat exchanger to keep the patient warm, but tainted water from inside the unit can be circulated into operating room air, where it can contaminate the exposed surgical site of the patient.

According to John Rihs, VP of Laboratory Services at Special Pathogens laboratory:

“Some of the devices remained positive for M. chimaera for months indicating that disinfection can be difficult.”

Rihs delivered the alarming news of the link between M. chimaera and heater-cooler units at the 44th Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC).

Rih’s analysis was based on a study of 89 heater cooler units in 23 hospitals throughout Canada and the U.S. between July 2015 and December 2016.

This same analysis found 1 in 3 heater cooler devices testing positive for the bacteria M. chimaera.

Stockert 3T Systems are heater-cooler devices that have water tanks providing temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.

Although the water in the 3T System circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.

According to the CDC, approximately 60 percent of heart bypass procedures performed in the U.S. utilize the Stockert 3T device that has been associated with these infections.

On June 1, 2016, the FDA issued a Safety Communication noting the link between M. chimaera infections associated with the use of the 3T heater-cooler system.

According to the FDA, devices produced prior to August 2014 were found to have M. chimaera contamination on the production line and water supply at the 3T manufacturing facility.

To date, the FDA is not aware of infections that occurred with 3T devices manufactured after September 2014.

In October 2016, the CDC estimated that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.

The CDC and the FDA are continuing to evaluate this risk and we may see the number of individuals at risk grow as it takes a significant amount of time to develop symptoms of this deadly bacteria.

According to the Centers for Disease Control and Prevention (CDC), the substantial horizontal airflow generated by heater-cooler units might disrupt vertical ultraclean airflow, which could be a potential mechanism for transmission of pathogens from a contaminated heater-cooler unit to a surgical site.

The CDC released a Health Alert Network Advisory to help hospitals and healthcare providers identify and inform patients who might have been put at risk.

Many hospitals have been sending out Patient Advisory Letters to warn of the potential risk of infection.

The FDA is collaborating with “professional societies, public health partners, heater-cooler manufacturers, and infectious disease specialists to evaluate additional strategies for mitigating infections associated with heater-cooler devices.”

The agency is urging hospitals and medical clinics to use extreme caution when cleaning and disinfecting heater-cooler units, and also to ensure that they are using the most up-to-date version of the manufacturer’s instructions when doing so.

M. chimaera is a deadly bacteria that is often found in soil and water but is rarely associated with infections.

However, patients exposed to the bacteria through open-heart surgery can develop general and nonspecific symptoms that often take months to emerge leading to misdiagnosis in many cases.

M. chimaera is fatal to nearly half the patients diagnosed with the bacteria.

M. Chimaera is a type of nontuberculous mycobacterium (NTM) classified as a slow grower.

In addition, detecting M. Chimaera is difficult because patients may not develop symptoms or signs of infection for months to years after initial exposure.

The first symptoms of the infection is an unexplained fever that lasts more than one week.

Other symptoms of M. chimaera include:

• Low energy
• Night sweats
• Joint or muscle pain
• Redness, heat, or pus around the surgical incision
• Difficulty breathing
• A persistent cough
• A cough with blood
• Nausea and vomiting

M. chimaera is fatal to approximately half the people who contract the infection.

According to the FDA, of the 32 cases occurring between 2010 and 2015, nearly half the patients died.

All of these patients had surgeries utilizing the Stӧckert 3T heater-cooler system.

If you had Cardiothoracic surgery, here’s a few tips to stay safe:

• Be aware!  Most cardiopulmonary bypass procedures involve the use of a heater-cooler device.
• Talk to your doctor about your risk of exposure to M. chimaera,
• Recognize the signs and symptoms of NTM infection
• Contact your health care provider at the first sign of these symptoms
• Report any problems to the FDA

The Children’s Hospital of New Orleans announced that at least twelve children who underwent cardiac surgery at Children’s Hospital between late May and July 2017 developed mycobacterium abscesses.

According to the hospital statement, the children were infected by a piece of equipment used to regulate the temperature of patients while on bypass – a heater-cooler unit.

October 2016 – This was the largest amount of cases reported, and nearly half of the patients died from the infection.

The infection is very serious and is also very slow to develop — meaning the link to cardiac surgery may not immediately be recognized.