INDIANAPOLIS — Several Central Indiana hospitals are warning thousands of open-heart-surgery patients about a risk of infection linked to a medical device used during the procedure, according to the Indianapolis Star.
The Centers for Disease Control and Prevention issued a warning in October that some LivaNova Stöckert 3T heater-coolers may have been contaminated during manufacturing, putting patients at risk of life-threatening infections. The devices help keep a patient’s circulating blood and organs at a specific temperature during open-heart surgery.
IU Health said five of its hospitals — Methodist, Indiana University and Riley Hospital for Children in Indianapolis, Arnett in Lafayette, and Bloomington — used the device. In a statement, the hospital system said it is in the process of notifying about 6,500 patients who received open-heart surgery from Jan. 1, 2012, through Nov. 30, 2016.
About 150,000 heart bypasses in the United States each year involve use of the device, according to the CDC.
The CDC estimated that in hospitals that used the devices and where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. Although the infections could be severe and some patients have died, the CDC said it is unclear whether the infection was a direct cause of death. Patients who had valves or prosthetic products implanted are at higher risk of the infection, according to the CDC.
Between January 2010 and August 2015, the Food and Drug Administration received 32 reports of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination. Twenty-five of those were reported to the FDA in 2015, according to its website.
Twenty-five of the 32 reports involved health care facilities outside the United States. In some cases, the FDA said, patients presented with infections several months to years after their surgical procedures.
The CDC said patients who have had open-heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue or unexplained fever.
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