Oct. 28, 2016

Dear Health Care Provider:

Tucson Medical Center is notifying providers of recent findings from Centers for Disease Control and Prevention and Food and Drug Administration regarding patients who have undergone open-chest cardiac surgery. Heater-cooler devices used during certain major surgeries that require the use of a heart/lung bypass machine have recently been linked to a rare bacterial infection caused by Mycobacterium chimaera, a slow-growing species of nontuberculous mycobacteria, or NTM.

Investigations into several clusters of infections linked to exposures to LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices during cardiac bypass surgery have determined that these devices were likely contaminated during manufacturing. TMC began using this device in July 2013 and has permanently taken it out of service.

CDC is recommending that clinicians, including cardiologists and general practitioners who take care of cardiac surgery patients before and after their surgery, be aware of the risk and consider NTM as a potential cause of unexplained chronic illness. Infections can take months to years after surgery to develop, and symptoms are often general and nonspecific. As a result, diagnosis of these infections is often missed or delayed, making these infections especially difficult to treat. There is no test to determine whether a person has been exposed to the bacteria. A test can identify infection once symptoms begin, but results can take about two months.

Symptoms of an NTM infection may include:
• night sweats
• muscle aches
• weight loss
• fatigue
• unexplained fever

Patients with NTM infections following cardiac surgery have presented with a variety of clinical manifestations, including endocarditis, surgical site infection, or abscess and bacteremia. Other manifestations include hepatitis, renal insufficiency, splenomegaly, pancytopenia and osteomyelitis.

When seeing patients with possible NTM infections and a history of cardiac surgery, clinicians should consider arranging consultation with an infectious disease specialist. If an NTM infection is suspected, it is important to obtain acid fast bacilli, or AFB, cultures from an infected wound and/or blood to increase the likelihood of identification of the organism and to obtain an AFB smear in order to have preliminary information while awaiting culture results.

In our letter to patients, we encourage them to discuss any symptoms with their primary care physician or surgeon or to call our administrative offices.

We are working with the Pima County Health Department to guide our response and will continue to partner with CDC and FDA to ensure we are following all safety recommendations.

Other resources that might be useful include:
Information from the FDA at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm520191.htm

As well as information from the CDC at https://www.cdc.gov/hai/outbreaks/heater-cooler.html

If you have additional questions, please contact TMC Administration, (520) 324-2535.