Several hospitals are warning thousands of open-heart-surgery patients about a risk of heater-cooler infection linked to a LivaNova device used during the procedure.

The Centers for Disease Control and Prevention issued a warning in October that some LivaNova Stockert 3T heater-coolers may have been contaminated during manufacturing, putting patients at risk of life-threatening heater-cooler infection.

The devices help keep a patient’s circulating blood and organs at a specific temperature during open-heart surgery.

Hospitals Warn of Heater-Cooler Infection Risk

The following seven hospitals have issued warnings to cardiac surgery patients about the risk of nontuberculous mycobacterium infection (NTM) reportedly linked to the LivaNova heater-cooler device.

• WellSpan York in Pennsylvania said its hospital began notify about 1,300 patents who received open-heart surgery in October 2015. WellSpan says that as of September 2016, 12 York Hospital patients contracted heater-cooler infections.
• Penn State Hershey Medical Center contacted about 2,500 open-heart surgery patients in November 2015. Three patients have reportedly been diagnosed with heater-cooler infection.
• Mercy Medical Center-Des Moines sent letters to about 2,600 open-heart surgery patients in August 2016. Two patients so far have acquired a heater-cooler infection.
• In September 2016, Penn Medicine warned hundreds of patients of heater-cooler infection risk. Three patients at Penn Presbyterian Medical Center in Philadelphia contracted heater-cooler infection.
• Mayo Clinic in Rochester, Minn., began notifying17,000 open-heart surgery patients that they may be at risk of heater-cooler infection in November 2016. One patient at the Rochester hospital contracted an NTM infection.
• In December 2016, Baystate Medical Center started notifyingroughly 1,500 to 1,800 cardiac patients of heater-cooler infection risk. As of Dec. 8, there have been no reports of patients with infection.
• Francis Hospital & Medical Center in Hartford, Conn., warnednearly 3,000 open-heart surgery patients of heater-cooler infection risk in December 2016. None of the hospital’s patients had a confirmed or suspected infection as of Dec. 9.

What is a Cardiac Heater-Cooler?

Heater-coolers are used during cardiopulmonary bypass surgeries—and other surgeries—that last six hours or less to help the patient’s body temperature stay at an optimal therapeutic level, ensuring the best opportunity for recovery.

The LivaNova Stockert 3T heater-cooler was formerly known as the Sorin heater-cooler. Sorin and Cyberonics merged and created a new company, called LivaNova. Sorin itself has received a warning letter from the FDA concerning the heater-cooler.

Risk of Heater-Cooler Infection Following Heart Surgery

According to a warning from the FDA, the LivaNova 3T heater-cooler system has been linked to nontuberculous mycobacterium (NTM) infections, a rare but potentially life-threatening infection caused by a bacterium (Mycobacterium chimaera) usually found in soil or water. Many patients who develop an NTM infection do not respond to antibiotics.

This makes an NTM infection especially serious for patients whose immune systems are compromised, such as patients who have just undergone invasive cardiopulmonary surgery and received prosthetic material.

“FDA believes these NTM infections associated with the 3T are rare,” the June 1, 2016, FDA warning stated. “However, they are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”

The Centers for Disease Control (CDC) state that LivaNova heater-cooler devices account for around 60 percent of heater-cooler devices used in the United States for approximately 250,000 heart bypass surgeries.

If you or a loved one has suffered a heater-cooler infection due to the use of a LivaNova heater-cooler, contact an experienced attorney for a free evaluation of your claim.