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.
Heater-Cooler Class Action Filed in Iowa
May 2017 — A woman from Iowa filed a class action lawsuit (PDF) for everyone in Iowa who was exposed to M. chimaera, M. abscessus, and other potentially deadly types of Non-Tuberculosis Mycobacterium (“NTM bacteria”) bacteria from a Sorin/LivaNova Stӧckert 3T heater-cooler machine. Click here to read more.
Heater-Cooler Infection Victim Files Lawsuit
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.
Class Action Lawsuit in Pennsylvania
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. LivaNova — Case No. 1:16-cv-00260.
What is a Heater-Cooler?
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.
Study Finds NTM Bacteria in 86% of Heater-Coolers
In January 2017, a study found M. chimaera in 86% of heater-cooler machines (18 out of 21) at five heart-surgery departments in Denmark. The researchers said it was likely that most heater-coolers made in the last 8-10 years were contaminated and it may be a general problem of the machines. The contaminated units included the Stockert 3T (14 out of 16 contaminated) and a Maquet Heater-Cooler (4 out of 5 were contaminated).
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.
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:
- Redness, heat, or pus at the incision site
- Muscle pain
- Joint pain
- Night sweats
- Abdominal pain