Medical Device Exposed Patients To Dangerous Infection

Defective Products | October 18, 2016

In October 2015, the U.S. Food and Drug Administration issued a safety communication regarding a heater-cooler device originally manufactured by Sorin Group Deutschland GmbH. The Stӧckert 3T Heater-Cooler System has been linked to an increased risk of infection with the Mycobacterium chimaera. These infections, referred to as non-tuberculosis mycobacteria (NTM) infections, can lead to serious health complications and even death. The Sorin Group has since partnered with another company and now does business under the name LivaNova.

Who Has Been Exposed?

The 3T Heater-Cooler System can be used in a range of surgical procedures. They regulate the temperature of blankets used on patients under anesthesia. The device is also used on oxygenator and cardioplegia heat exchangers. Heater-cooler devices are used during many cardiothoracic and cardiovascular surgeries, though they can be used in anything from an orthopedic operation to plastic surgery. Any patient undergoing a procedure where their body temperature was regulated during the operation could have been exposed. The Centers for Disease Control and Prevention issued a warning last week regarding patients who were exposed to the device during open-heart surgeries.

What Does An NTM Infection Look Like?

One of the challenges of this type of infection is that they can be slow to develop and are not easy to spot. In some cases, people who are exposed do not have symptoms for months or even years. When the infection develops, it can present any of a number of symptoms, including:

  • Cough
  • Recurrent or persistent fever
  • Night sweats
  • Weight loss and loss of appetite
  • Lethargy
  • Shortness of breath/difficulty breathing
  • Chest pain
  • Joint or muscle pain

The CDC advisory is important because the symptoms do not paint a clear picture of the severity of an NTM infection. In the most serious cases, these infections are fatal.

Next Steps

Patients who were exposed to this heater-cooler device, as well as their doctors, should be made aware of the danger. The affected patients need to be monitored for signs of infection to ensure a quick and aggressive treatment plan is put in place. Health care providers should be working now to make sure all affected patients are kept informed.

Source: STAT News, “Open-heart surgery devices putting patients at risk, CDC warns,” by Eric Boodman, 13 October 2016 

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