Children's Hospital Colorado
Heart institute
Heart institute

Update Regarding CDC Findings on Contaminated Heater-Cooler Devices

Children’s Hospital Colorado is notifying patients and families who have had open-heart surgery about a potential infection risk. While the risk to our patients is extremely low, we wanted to alert all of our patients.

The CDC and Food and Drug Administration (FDA) are investigating reports that a common device used to heat and cool the blood during cardiac open-heart surgery has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). The chances of getting this infection from open-heart surgery are less than 1%.

There are inherent risks with any procedure. These heating and cooling devices are essential to the success of open-heart surgeries, and there are no other acceptable devices for us to use at this time. Children’s Colorado is following all recommendations from the CDC, FDA and the manufacturer to minimize any possible risk to patients.

We also have conducted and will continue to conduct diligent surveillance for the bacteria. To date, the bacteria have not been found in our heating and cooling devices or in any of our cardiac surgery patients. We have evaluated all patients with post-operative infections as far back as 2007 and found zero patients with any mycobacterium infections, including Mycobacterium chimera.

This infection cannot be spread from person to person. It is very slow growing and difficult to diagnose. The symptoms of infection are nonspecific and thus, could be related to other more common causes of infection.

Again, we want to stress that the potential of this infection is incredibly low. However, if you have any questions or concerns, please contact your cardiologist. You also can find additional information on the CDC website.

Please know that quality and safety are always a top priority at Children’s Colorado. Like you, we only have our kids’ best interests at heart.

Frequently asked questions

Why am I hearing about bacteria causing problems in heart patients in the news?

Bacteria commonly found in soil, called Mycobacterium chimera, have been linked to contamination of heater-cooler machines (Sorin 3T) that are used to warm and cool a patient’s body during heart surgeries. Children’s Hospital Colorado has had these machines in use for this purpose since 2010. Infections with these bacteria have been found in some adult patients at hospitals in the U.S.

How likely is it that my child is infected?

The risk to your child is extremely low. We have done an evaluation and have no evidence of this bacterial infection in our heart patients or from our heater-coolers.

Should my child be tested for Mycobacterium chimera?

The Centers for Disease Control (CDC) does not recommend routine testing for patients who had heart surgery and had been exposed to the heater cooler device.  Our hospital laboratory team, along with our infection prevention team and heart team, are in agreement with the CDC’s recommendations.

If your child is experiencing symptoms associated with these types of infections, such as night sweats, weight loss, muscle aches or unexplained fever, you should seek medical care.  If you are concerned about your child having these symptoms, we advise speaking with your child’s cardiologist who can evaluate your child and provide further recommendations.

What is a Sorin 3T Heater-Cooler and why did we use it in the first place?

The heater-cooler helps carefully adjust a patient’s temperature in the operating room to ensure that they have the correct temperature during different portions of their heart operation.  We control a patient’s temperature closely because a too high or too low temperature can hurt the brain or the heart. The heater-cooler does not come in contact with the area where the surgery is being performed. There is, however, an air filtration system that circulates air on the heater-cooler.  Investigations by the Food and Drug Administration (FDA) and the CDC have indicated that these devices may be able to move these bacteria into the air and could result in an infection.

How was it found?

In 2015, a team of investigators in Europe reported a cluster of adult patients who had previously undergone heart surgery and were infected with these bacteria and all had undergone open heart surgery using these heater cooler devices. A similar outbreak was reported in adult heart patients in Pennsylvania and Iowa. The Food and Drug Administration and Centers for Disease Control began investigating these reports back in 2015. Sorin (now known as Liva Nova) is the company that makes these devices and had sent out updated cleaning and disinfection instructions to hospitals at the same time. Children’s Hospital Colorado followed all recommendations from the company as information was available.

What have we done to help keep our patients safe?

  • In 2015
    • Reviewed and implemented new manufacturer’s instructions for cleaning and disinfection.
    • Performed a review of any patient who had heart surgery here at CHCO as far back as 2007 looking for any infections related to these bacteria and found no related patient infections.
    • We placed requests to the company to perform a site visit and complete a process for cleaning and disinfection and replacement of some parts which they completed.
    • Ordered all new valves, tubing and other accessories used with the heater coolers and replaced them at the time of the Sorin visit.
    • Performed tests of the water inside the heater coolers to look for any evidence of these bacteria. These tests did not show any Mycobacterium chimera.
    • Followed all guidelines from the FDA and Sorin regarding use of the heater coolers including turning them away from the surgical field and moving them as far from the patient as possible.
    • Worked closely with our Infection Prevention, Biomedical and Cardiac Surgery Departments to ensure the safest process for our patients.
  • In 2016
    • Sending letters out to families that may have been affected to let them know about this growing concern (so far we’ve sent out 1100 letters and will send out 3000 more)
    • Stopped using the Sorin heater cooler devices.
    • Used another device that is able to appropriately control the patient’s temperature during these surgeries.
    • The Sorin Heater Coolers will only be used in the case of an emergency and don’t have access to a different device.
    • Created a hot-line for parents who wish to speak with one of our team members about this concern.

Why are you using this machine in emergency situations?

Unfortunately due to national shortage of alternative machines, we will not receive another machine until January of 2017. Since we have not found any evidence of these bacteria in our patients or in the heater-cooler, it is safer for us to perform a life-saving surgery.

Is this only happening at Children’s Hospital Colorado?

No, this machine is used in both pediatric and adult heart surgery so there are lots of hospitals who are concerned about this issue. From information given by the CDC, there are approximately 150,000 patients a year who have been exposed to this machine.

Where can I get more information?

We are happy to have one of our heart experts call you and talk with you about your concerns. Our hotline number is: 720-777-0131

Additional resources on the Children's Colorado website: