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Heater-Cooler Lawsuits: Bacteria Infection Lawsuits

Commonly asked questions about heater-cooler systems:

What are Heater-Cooler Systems?

Heater-cooler systems are used during cardiothoracic surgery (open-heart surgery) and other medical procedures to warm or cool patients in order to optimize care and improve outcomes.

The heater-cooler devices feature water tanks that transport temperature-controlled water to external heat exchangers or warming-cooling blankets through closed circuits.

The quiet running system is said to deliver effective blood temperature management control during cardiopulmonary by-pass and other related cardiovascular procedures, according to Cincinnati Sub-Zero, a medical device company that manufactures the Hemotherm CE heater-cooler system.

However, according to multiple reports, it’s possible for the water used in several systems, including the 3T system — a heater-cooler device manufactured by LivaNova PLC — to become contaminated, which can result in bacteria, including nontuberculous mycobacterium, to be released into the air through the system’s exhaust vent. As a result, patients may be been exposed to the harmful bacteria.

Why Are Heater-Cooler Devices Reportedly Dangerous?

The U.S. Food & Drug Administration (FDA) recently warned that heater-cooler systems used during open-heart surgery and other medical procedures may transmit bacteria and cause infections, such as mycobacterium chimaera, resulting in severe injury or death.

Thousands of surgeries have allegedly been performed using contaminated heater-cooler equipment. Victims of harmful heater-cooler devices allege in lawsuits that the water in the heater-cooler system’s reservoir can become contaminated and spray into the air. As a result, severe — and possibly fatal — infections can result.

Claims are currently being filed against LivaNova PLC, the manufacturer of the 3T heating-cooling system, because the device has been found to transmit bacteria into patients during surgeries, namely open-chest cardiac procedures.

Common Symptoms of Nontuberculous Mycobacterium Infections

Patients exposed to contaminated water in the heater-cooler device may experience the following side effects:

  • Fatigue
  • Unexplained fever
  • Sudden weight loss
  • Night sweats
  • Muscle aches
  • Myalgia
  • Malaise
  • Blood in the sputum (phlegm)

Editor’s note: There can be a very long delay (up to several years) between the time a patient is exposed to the bacteria and an infection occurs.

Serious Complications of Nontuberculous Mycobacteria Infections

Patients who have undergone cardiac surgery should be weary of the following serious complications:

  • Endocarditis
  • Surgical site infection
  • Abscess
  • Bacteremia
  • Hepatitis
  • Renal insufficiency
  • Splenomegaly
  • Pancytopenia
  • Psteomyelitis

Editor’s note: Potential complications may occur up to four years after undergoing cardiac surgery.

Which Companies Manufacture Heater-Cooler Systems?

The following medical device companies manufacture heater-cooler systems:

LivaNova is currently conducting extensive testing and data collection in an effort to understand how nontuberculous mycobacterium (NTM) transmission may be occurring during the use of heater-cooler devices. According to the medical device manufacturer, the current thinking is as follows:

• The failure to clean and disinfect a water circuit of a heater/cooler can allow biofilm formation. Nontuberculous mycobacterium is known to proliferate in biofilm and may lead to contamination of the heater/cooler water circuit.

• In operation of the heater-cooler device, air bubbles may be generated in the water tanks and then exit the device as aerosolized particles. The NTM present in the water may be carried by aerosolized particles out of the tank.

• Via air flow, the aerosolized particles may then be dispersed into the surrounding environment.

• The state of scientific knowledge provides no evidence that nontuberculous mycobacteriumcan be transmitted via water evaporation because water molecules formed by evaporation are too small to carry the bacteria.

Surgeries That May Include Use Of Heater-Cooler Device:

The following types of surgeries may require or include the use of a heater-cooler system:

  • Heart valve replacement
  • Heart transplant
  • Lung transplant
  • Coronary artery bypass graft (CABG)
  • Extracorporeal membrane oxygenation (ECMO)
  • Left ventricular assist device (LVAD) implant
  • Aortic anomaly surgery
  • Pulmonary artery banding
  • Lung resection

FDA Releases Warning About Heater-Cooler Devices

The FDA released its first warning about heater-cooler devices and NTM infections in October 2015.

Two months later, the federal agency sent a warning letter in December 2015 to the Sorin Group, maker of a heater-cooler device linked to infections and deaths at a Pennsylvania hospital. According to the FDA, the Italy-based company failed to provide adequate information regarding how its new cleaning procedures prevent biofilm from growing in the heater-coolers.

CDC Issues Recommendations About Dangers of Heater-Coolers

The Centers For Disease Control and Prevention recently issued recommendations to health officials, healthcare providers and facilities to keep an eye out for nontuberculous mycobacteriumcan infections among patients who have undergone cardiac surgery, and to take all necessary precautions in order to prevent such illnesses.

“The most important action to protect patients will be to remove contaminated heater-coolers from operating rooms, and ensure that those in service are correctly maintained,” the agency issued in a statement. “Patients who might have been exposed to NTM during a surgical procedure should continue to look for signs of potential infection and keep in touch with their clinicians for further evaluation. Due to the potentially long delay between exposure to NTM and manifestation of clinical infection (up to several years), identifying infections related to the use of heater-cooler devices can be challenging.”

Can I File A Heater-Cooler Lawsuit?

Our heater-cooler lawyers can help if you or someone you care about contracted a severe — or possibly fatal — infection as a result of being exposed to bacteria from a contaminated heater-cooler device. Our top heater-cooler lawyers are handling individual litigation nationwide and currently accepting new heater-cooler cases in all 50 states.

Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed by a heater-cooler system.

Our No-Fee Promise On Heater-Cooler Device Cases

You can afford to have our great team of heater-cooler lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:

  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a heater-cooler settlement
  • Phone calls are always free

How Do I Start A Heater-Cooler Claim?

Our heater-cooler lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-3417 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have a claim, we will start immediately.

WARNING: There are strict time deadlines for filing heater-cooler lawsuit claims.

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References

  • Mycobacterial infections associated with heater cooler units used in cardiac surgery: advice for providers of cardiac surgery. London: Public Health England; 2015.
  • Wellspan York Hospital, Wellspan York Hospital Notifies Open Heart Surgery Patients of Possible Infection Risk: October 26, 2015.
  • The Pennsylvania Department of Health, Cluster of Nontuberculous Mycobacterium Infections Identified in WellSpan York Hospital Patients: October 26, 2015.