Open-heart surgery patients may have been exposed to rare bacteria

CHARLOTTE, N.C. — Thousands of patients who had open-heart surgery at certain Charlotte-area hospitals may have been exposed to a rare bacteria.

Four hospitals

Action 9 investigator Jason Stoogenke found out that a common medical device that Carolinas HealthCare System, or CHS, used to warm or cool blood and organs may have been contaminated at four hospitals: CMC, Mercy, Northeast and Pineville.

Action 9 investigator Jason Stoogenke broke this story.

Four years

CHS is warning 4,600 patients, saying anyone who had open heart, vascular or liver transplant surgery in the past four years could be at risk.

CHS said there are no confirmed cases locally, but is sending patients warning letters out of an "abundance of caution."

[READ CHS' LETTER TO PATIENTS]

"It scared me to death," Albemarle resident Randle Chandler said about getting the letter.

Chandler underwent heart-bypass surgery at CHS NorthEast in Concord.

"I'd like to know if I have the infection or not," he said.

CHS still using device

CHS still uses the device but told Action 9 it's using "enhanced cleaning techniques" and "has expanded the use of a different type of machine in surgeries where heater-cooler machines are not required."

The company that made the unit reported contamination during production in 2014.

In 2015, the manufacturer recalled the instruction manual, but not the device itself, saying the device was too important for life-saving surgery to take it off the market, even temporarily.

Symptoms

The Centers for Disease Control and Prevention and U.S. Food and Drug Administration have reported patients coming down with the rare bacterial infection, mycobacterium chimaera, nationwide.

[FDA warning on Mycobacterium chimaera Infections]

CHS said there are no confirmed cases locally, but it can take months or even years for symptoms to surface, so it can be hard to detect early and that can lead to complications.

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Symptoms include fever, sweating, unexplained weight loss, fatigue and redness or drainage at the surgical site.

The infection is not contagious.

The Centers for Diseases Control and Prevention says there's a very low risk of anyone becoming infected. Patients with prosthetic implants are at higher risk.

The bacteria occurs naturally in soil and water, but rarely infects people. There's no test to determine if you have the infection and no antibiotics to ward it off.

Novant statement:

Novant Health used the Stöckert 3T heater-cooler device at two hospitals: Novant Health Presbyterian Medical Center Novant Health Forsyth Medical Center.

"Novant Health has had no known cases of this infection. We have replaced the equipment with the recommended new heater-cooler devices from a different manufacturer. We are also communicating directly with our patients and primary care physicians to be sure that they are aware of this issue."

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