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Thousands of Central Indiana Open Heart Surgery Patients At Risk

Steve Wagner

In October, the Centers for Disease Control and Prevention (CDC) released a warning that a key piece of equipment used in open-heart surgeries was possibly contaminated during manufacturing and poses a risk to open-chest open heart surgery patients. Though the CDC and U.S. Food and Drug Administration published information and alerts about the potentially contaminated heater-cooler devices in 2015, several Central Indiana hospitals are informing patients now about the infection risk, which has impacted 32 patients thus far.

IU Health is in the process of notifying around 6,500 open heart surgery patients who underwent their procedures between January 1, 2012 and November 30, 2016. The involved hospitals include Methodist, IU, and Riley Hospital for Children in Indianapolis, as well as Arnett in Lafayette and Bloomington. Franciscan Health sent notification letters to around 800 patients receiving procedures at their Indianapolis, Crown Point, and Lafayette facilities. The Richard L. Roudebush VA Medical Center also sent letters to several hundred former surgical patients. Community Health Network was in the process of notifying around 600 patients, though they discontinued their use of the device after the CDC’s 2015 warning. St. Vincent Health and Eskanazi Health do not use this particular type of device in open heart surgery.

LivaNova Stockert 3T Heater-Cooler Used in 150,000 Surgeries Each Year

The device in question is the LivaNova Stockert 3T Heater-Cooler. During open heart surgery, the body needs help to continue circulating blood and also to maintain a safe body temperature for the patient’s blood and organs. An incredibly popular device, it’s used in about 60% of all open heart surgeries in the United States.

The bacteria that has potentially been introduced into the devices during manufacturing is Mycobacterium Chimaera (M. chimaera), a type of nontuberculous mycobacteria. It is often found in soil and water. For healthy people, the risks of serious effects from an infection are very small. For those with compromised immune systems or other serious health issues (such as those requiring open heart surgery), an infection can be deadly. Problematically, when introduced into the blood during open heart surgery, an M.chimaera infection can nonspecific symptoms that are likely to be misdiagnosed or leave diagnosis delayed for months or even years. By the time a proper diagnosis is made, it is incredibly difficult to treat.

Surgical Patients Urged to Watch for Symptoms

If you are a patient who had open heart surgery, you the CDC and local hospitals urge you to monitor your health closely. Symptoms of an M. chimaera infection include night sweats, muscle aches, weight loss, fatigue, and/or unexplained fever. Though there is no test to determine if you have been exposed, your blood can be tested for presence of infection. If you had a valve or prosthetic device implanted during your open heart surgery, you may be even more at risk.

Victims of this faulty product entered an operating room expecting to come out feeling better. Instead, the heater-cooler device may have made them even more sick. In rare cases, the infection could lead to death. If you were diagnosed with M. chimaera infection after open heart surgery, contact the product liability and medical malpractice attorneys at Wagner Reese. We offer a completely free initial consultation and never charge a fee unless your case is settle or won. Call us today to find out what we can do for you: (888) 204-8440.


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