Warning: Heart Patients May Be at Risk from a Medical Device Used During Surgery

If you have had heart surgery between 2010 to 2016, you may be at risk of a life-threatening infection linked to a medical device used during your procedure.  The device is the Stockert 3T heater-cooler which is commonly used to heat and cool a patient’s blood during the operation.

Before you panic, government health officials say the risk of infection is generally very low and is not contagious.

Still, the U.S. Food and Drug Administration and U.S. Centers for Disease Control have received at least 91 reports of patients who developed a nontuberculous mycobacterium (NTM) infection linked to the heater-coolers. Worldwide, the infections have resulted in at least 12 patient deaths, according to the FDA.  A total of about 600,000 patients in the United States who have had heart operations involving the machines are at risk.

If you, or someone you know, has had heart surgery within the past six years, it’s important to contact your surgeon and hospital if you haven’t heard from them already.

Symptoms of NTM include night sweats, muscle aches, joint pain, weight loss, fatigue and unexplained fever.

WTHR (NBC Indianapolis) reported Wednesday night (12/29/16) that several Indiana hospitals are now sending warning letters to their heart surgery patients.

Like many other hospitals across the United States, Franciscan Health hospitals in Indianapolis, Crown Point and Lafayette had used the device. Franciscan Health has contacted patients who may have been at risk. The patients’ physicians also were notified.

In Indiana, IU Health, The Roudebush VA Medical Center, and the Community Health Network have also sent such warning letters to their open heart patients.

Eskenazi and St. Vincent hospitals reported to WTHR that they did not use the heater-cooler devices that triggered the warning and, therefore, are not sending any warning letters to patients.

A spokesperson for IU Health says the heater-cooler units were used during heart operations at its Methodist, University, Arnett, and Bloomington hospitals.  “We have no reported cases of the infection, and our physicians are aware of the situation as they provide patient care.”

The Indiana Department of Health says it is not aware of any NTM cases linked to the heater-cooler units. Nearby states such as Michigan, Iowa and Minnesota have reported infections. The pulmonary illness can develop slowly over the course of months or years, and it can take more than a year of antibiotic treatment to cure.

“It’s important to remember this isn’t just a VA thing or an Indianapolis thing. It’s a national thing,” said Roudebush VA Medical Center spokesman Pee Skovill. “It’s very unfortunate it happened, but it’s a manufacturer issue that’s out of our control.”

The attorneys at Theodoros & Rooth have decades of experience in successfully litigating personal injury cases, including medical malpractice and hospital or nursing home negligence.  If you or someone you know was seriously injured due to a doctor, nurse, or a defective medical product, call Theodoros & Rooth right away. The initial consultation is always free.  If we believe you have a case, the attorneys at Theodoros & Rooth will represent you fairly and aggressively to get you the compensation that you deserve.  Call or contact us from our website at anytime for a free consultation.

Sources for this article include WTHR, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control