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
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.