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Heater-Cooler FAQ

Click here for frequently asked questions (FAQs) to problems with heater-cooler devices used during open-heart and other invasive surgeries.

Heater-cooler devices used during open-heart surgery and other invasive procedures have been linked to life-threatening infections, according to the U.S. Food & Drug Administration (FDA).

Free Confidential Lawsuit Evaluation: If you suffered an infection or other injury after undergoing surgery in which a heater-cooler device was used, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.

What is a Heater-Cooler Device?

Heater-cooler combos are used to warm or cool patients during surgeries involving the heart, lungs, esophagus, and other chest organs (cardiothoracic surgery). The devices include tanks which provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits.

What’s the Problem?

In October 2015, FDA issued a Drug Safety Communication stating that the Stӧckert 3T heater-cooler device made by LivaNova had been linked to at least 32 reports of nontuberculous mycobacterial (NTM) infection. Only 8 of the reports came from inside the U.S, associated with 3 events describing patient infections. The rest mainly came from Western Europe, according to the FDA.

How Can a Heater-Cooler Machine Cause an NTM Infection?

Heater-cooler units use water tanks to provide temperature-controlled water to keep patients warm or cool during surgery. Although the water does not come into contact with patients, FDA is warning that contaminated water could enter other parts of the device, which could then be sprayed through its exhaust vent.

What are the Symptoms of an NTM Infection?

  • Night sweats
  • Muscle aches
  • Weight loss
  • Fatigue
  • Unexplained fever

Is There a Class Action?

No class action lawsuit has been filed over injuries alleged from heater-cooler units. However, lawyers have requested that a multidistrict litigation (MDL) be created to centralize the lawsuits in South Carolina, where 10 out of 15 lawsuits are currently pending.

Have There Been Any Settlements?

The heater-cooler litigation is still in its early stages, and there have been no reports of any significant settlement offers. However, our lawyers feel that as the number of lawsuits filed over the devices continue to grow, manufacturers will eventually enter settlement negotiations with the plaintiffs.

Which Injuries is your Law Firm Accepting?

You may qualify to participate in a heater-cooler lawsuit if you:

  • Had open chest surgery (heart and/or lungs) from 2006 to the present;
  • Developed life-threatening (hospitalization) infection within 2 years of surgery.

Do I Have a Heater-Cooler Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in heater-cooler lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Case Evaluation: Again, if you got an infection from a heater-cooler machine, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.

Free Confidential Case Evaluation

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