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FDA Warns Recent Heart Surgery Patients of Infection Risk

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October 13, 2016 — Over 500,000 people who recently had open-heart surgery in the United States may have been exposed to a deadly bacteria that can take years to cause symptoms, according to a warning from the FDA.

The problem is the Stӧckert 3T Heater-Cooler System (3T) made by LivaNova. It is a machine used during open-heart surgery to control the temperature of a patient by pumping water into a special blanket.

The water never touches the patient, but it evaporates and aerosolizes through the device’s exhaust vents. If the water is contaminated, bacteria could land on a patient during surgery and cause an infection.

The FDA said evidence “strongly suggests” the 3T Heater-Coolers had the same source of contamination — and it was probably a facility in Germany where the bacteria M. chiamara was found on the production line and water supply in August 2014.

In September 2014, the manufacturer added cleaning and disinfection procedures. Butt the FDA said some new 3T devices manufactured after September 2014 have tested positive for M. chiamara. Imports were banned in January 2016.

Here is a video of the problem from the CDC:

 

Over 250,000 open-heart bypass surgeries are performed in the United States every year, and about 60% involved the Stӧckert 3T heater-cooler devices, according to field notes from the CDC.

If the devices were contaminated in Germany, that means most people who recently had open-heart surgery in the United States were exposed to M. chiamara. However, only about 13,000 patients have been notified of the risk by hospitals that had outbreaks.

Six hospitals in Pennsylvania, Iowa, and Michigan notified patients after outbreaks between October 2011 and June 2016: Wellspan York Hospital (12), Penn State Hershey (5), Penn Presbyterian (4), University of Iowa (3), Mercy Medical Center (2), Spectrum Health (2).

These hospitals reported 28 cases, but it is likely that many more infections were never reported. The symptoms are vague and can take years to appear — fatigue, fever, aches and pains, redness or pus at the incision, night sweats, weight-loss, nausea, and vomiting.

Since January 2010, the FDA has received 32 reports of infections with M. chiamara, a type of Non-Tuberculosis Mycobacteria (NTM), associated with heater-cooler devices. The FDA issued a warning in October 2015 and has continued to provide updates to the public with new information. The last warning was in June 2016.

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