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  • Device Alert

Device Alert

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are investigating reports that a device used by CHKD and approximately 60 percent of hospitals performing open-heart surgery has been linked to a rare bacterial infection.

The infection associated with the device, which heats and cools the blood during surgery, is caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM). The chance of developing this infection is very low. The CDC estimates the risk to be less than 1 percent.

CHKD is not aware of any patients who had open-heart surgery at our hospital who have developed this infection, but we want our patients to know about it. Infections associated with this germ are very slow-growing and difficult to diagnose. It is possible to develop symptoms years after surgery, so it is important to make an appointment with your child’s primary care doctor if your child shows any symptoms of an NTM infection. These include the following:

  • Night sweats
  • Muscle aches
  • Weight loss
  • Fatigue
  • Unexplained fever

CHKD has notified patients and families who may be affected by this situation. We have also notified the medical community so that doctors who take care of cardiac surgery patients will be aware of the risk and consider NTM as a potential cause of unexplained chronic illness.

If you have additional questions or concerns about this information, please review the CDC's “Frequently Asked Questions” or contact your child's pediatrician.

As always, your child’s health and safety are our top priorities. We will continue to monitor this situation and share any updates via personal communication or our website, as appropriate. Thank you for the trust you place in us. We value our partnership on your child’s medical team.