An infection after heart surgery can be a devastating and, at times, fatal diagnosis. Multiple studies have found that the Heater-Cooler devices used operating rooms may be the cause of these heart surgery infections. The Stöckert 3T Heater-Cooler unit is a device used in open-heart surgeries to regulate a patient’s body temperature. Recent studies have found that these devices can cause deadly infections from bacteria that grow in the unit’s water tank and circulate through its exhaust fan. The bacteria contaminates patients when the exhaust fan blows tainted air over exposed wounds during surgery.
If you or a loved one has suffered an infection after an open heart surgery, contact one of the Minnesota defective medical device lawyers at Goldenberg Lauricella, PLLC for a free consultation.
Case Quick Facts
The Problem
Heater-Cooler units have been linked to infections since a 2002 German study found that germs and foreign particles can pollute the device. This pollution can lead to the development of a rare bacteria called Mycobacterium Chimaera that grows in the unit’s water tank. When the Heater-Cooler is used to blow warm or cold air over a patient during surgery, the bacteria is released into the operating room through the unit’s exhaust fan and can contaminate open wounds. This contamination can cause nontuberculous mycobacterium (NTM) infections, which can be fatal for those with weakened immune systems.
A graphic representing the transmission of air through Heater-Cooler units. Blue arrows represent cold water; Red arrows represent hot water. Courtesy of the FDA.
The Injuries
Patient exposure to Mycobacterium Chimaera can cause nontuberculous mycobacterial (NTM) infections. NTM infections can be fatal for those with weakened immune systems. The path to recovery for those exposed to NTM infections can be painful and arduous, because this bacteria is not typically tested for on culture tests. The symptoms of these infections are also common symptoms of many other conditions, so diagnosis can be difficult.
Symptoms of NTM infections include:
- Fever
- Redness, heat, or pus at the surgical site
- Joint pain
- Weight loss
- Nausea
- Fatigue
- Pain
- Muscle pain
- Night sweats
- Abdominal pain
- Vomiting
Goldenberg Lauricella Can Help
If you or a loved one has suffered an infection after heart surgery, please contact Goldenberg Lauricella, PLLC. We deliver the Gold standard advocacy you deserve.
2002: A German study links Heater-Cooler devices to bacterial contamination and infection.
2006: The Stöckert 3T Heater-Cooler unit is approved for use in 2006 and is used in approximately 60 percent of open heart surgeries in the United States.
2010: The U.S. Food and Drug Administration (FDA) is first notified of heart surgery infections linked to Heater-Cooler devices.
May 2014: A mycobacterium outbreak infects 15 patients at Greenville Memorial Hospital in South Carolina. Four of the patients die. Authorities cannot determine the source but find that the bacteria found in the hospital’s Heater-Cooler units closely resembled those linked to the outbreak.
July 2014: Sorin, the manufacturer of the Stöckert 3T Heater-Cooler unit, informs hospitals that its Heater-Cooler devices can be contaminated. Some units are found to be contaminated at the manufacturing facility.
April 2015: European health authorities warn hospitals about potential heart surgery infection risks related to use of Heater-Cooler devices.
October 2015: The FDA issues a safety alert linking mycobacterium infections to heater-cooler devices. Hospitals begin to warn patients who underwent an open-heart surgery that used a Heater-Cooler device of infection risk.
October 2016: The U.S. Centers For Disease Control (CDC) issues a report suggesting that Heater-Cooler contamination is more widespread than previously thought.
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Frequently Asked Questions
Why are people filing heater-cooler lawsuits?
The Stöckert 3T Heater-Cooler unit is a device used in open-heart surgeries to regulate a patient’s body temperature. It was found that the exhaust fan releases bacteria that can lead to a significantly increased risk of deadly postoperative infections within a contaminated patient. Symptoms may take many months to appear, resulting in increased potential for dire complications.
What is an NTM infection?
NTM stands for NonTuberculous Mycobacteria, which are pathogens that may cause serious illness or death. It was confirmed that patients with comprised immune systems who underwent open-heart surgery were infected by Mycobacterium chimaera, a type of NTM., due to contaminated Stockert 3T Heater-Cooler Units.
Do I have a heater-cooler case?
If you or someone you know has been diagnosed with an NTM infection after an open-heart surgery, you may have a case. Contact one of the defective medical device lawyers at Goldenberg Lauricella, PLLC for a free consultation. Time is critical since there are deadlines for filing these cases that could expire.