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Stӧckert 3T Heater-Cooler Lawsuit

Stӧckert 3T Heater-Cooler Lawsuit

The Stӧckert 3T Heater-Cooler is a machine used in open-heart surgery. It has been linked to dozens of infections with a deadly bacteria. A growing number of lawsuits have been filed against hospitals that had outbreaks.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Stӧckert 3T Heater-Cooler induced injury cases in all 50 states. If you or somebody you know was diagnosed with an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Hospital Sued by Heater-Cooler Infection Victim

In October 2016, a lawsuit was filed against Penn Presbyterian Medical Center by a man who developed a severe infection after open-heart surgery in 2014. He blames the heater-cooler machine for introducing bacteria that infected his aortic valve, caused several strokes, and required another open-heart surgery to replace. Click here to read more.

Heater-Cooler Class Action Lawsuit

In February 2016, a class action lawsuit (PDF) was filed by two men who were exposed to a deadly bacteria during open-heart surgery at two hospitals in Pennsylvania. Neither man developed an infection, but they are seeking compensation for follow-up care.

The class action was filed on behalf of everyone in Pennsylvania who open-heart surgery at WellSpan York Hospital (October 1, 2011 to July 24, 2015) or Penn State Hersey Medical Center (November 5, 2011 to November 5, 2015).

The lawsuit was filed in the U.S. District Court for the Middle District of Pennsylvania — In Re: Edward Baker and Jack Miller vs. LivaNovaCase No. 1:16-cv-00260.

Overview

The Stӧckert 3T Heater-Cooler is a machine made by LivaNova (formerly Sorin Group). It is used in the operating room during open-heart surgeries to control the body temperature of a patient who is anesthetized.

How Does a Heater-Cooler Work?

Heater-cooler machines pump temperature-controlled water into a special blanket that is draped over a patient. Water in the system never touches the patient, but it does evaporate and “aerosolize” through the machine’s exhaust vents. If the water contains bacteria, it can spray into the air and land on a patient during open-heart surgery.

Watch this video for a demonstration of the problem:

Evidence of Contamination at Manufacturer

In October 2016, the FDA said evidence “strongly suggests” that Stӧckert 3T heater-coolers were contaminated with a deadly bacteria at the same source — probably a facility in Germany where the bacteria was found in the water supply and on a production line in August 2014. Since then, new machines have tested positive for the bacteria. The FDA banned imports in January 2016.

Over 500,000 Heart Surgery Patients Exposed

It is possible that most — if not all — Stӧckert 3T machines in the United States could be contaminated. They have been in use since 2006. And because they are used in 60% of hospitals that perform open-heart surgeries, about 150,000 people have been exposed to the risk every year in the United States.

What is the Risk?

The risk is low. The FDA has only received 32 reports of infections associated with heater-coolers since 2010. However, it is likely that many more cases were never reported because the bacteria grows very slowly.

How Many Outbreaks Have Been Reported?

Six hospitals in Michigan, Iowa, and Pennsylvania have reported outbreaks since 2011. Over 13,000 patients were notified of possible exposure and 28 infections were reported. These hospitals include:

  • Wellspan York Hospital: 1,300 exposed — 12 cases (October 2011 to July 2015)
  • Penn State Hershey Hospital: 2,300 exposed — 5 cases (November 2011 to November 2015)
  • Penn Presbyterian Medical Center: 1,100 exposed — 4 cases (October 2013 to December 2015)
  • University of Iowa: 1,500 exposed — 3 cases (January 2012 to January 2016)
  • Mercy Medical Center in Iowa: 2,600 exposed — 2 cases (July 2012 to July 2016)
  • Spectrum Health Medical Center in Michigan: 4,500 exposed — 2 cases (January 2012 to November 2015)

What is the bacteria?

The bacteria causing the outbreaks is called M. chimaera, and it is commonly found in dirt and water. It is a type of Non-Tuberculosis Mycobacterium (NTM), and usually only infects people with weak immune systems or those who have recently had surgery.

Symptoms of Heater-Cooler Infection

The bacteria grows slowly and it can take up to 4 years before symptoms appear. Therefore, anyone who had open-heart surgery should seek medical attention immediately if they develop symptoms:

  • Fatigue
  • Fever
  • Pain
  • Redness, heat, or pus at the incision site
  • Muscle pain
  • Joint pain
  • Night sweats
  • Weight-loss
  • Abdominal pain
  • Nausea
  • Vomiting

Do I have a Stӧckert 3T Heater-Cooler Lawsuit?

The Schmidt Firm, PLLC is currently accepting Stӧckert 3T Heater-Cooler induced injury cases in all 50 states. If you or somebody you know was diagnosed with an infection, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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