On June 1, 2016, the U.S. Food and Drug Administration (FDA) issued a Safety Communication informing health care providers and patients of new information regarding the Stӧckert 3T Heater-Cooler System (3T device), manufactured by Sorin Group Deustchland GmbH. This communication provides an update to the FDA’s October 15, 2015 Safety Communication concerning Mycobacterium chimaera (M. chimaera) infections associated with the use of the all heater-cooler devices in patients who have undergone cardiothoracic surgeries. M. chimaera is a type of nontuberculous mycobacterium (NTM) that may cause death or serious injury. Although these infections are rare, they are hard to detect and patients may remain symptom free for months or years after initial exposure.
Since this original communication, the FDA obtained information linking M. Chimaera infections and one specific heater cooler model – the 3T device. The 3T device is often used during cardiothoracic surgeries (those involving treatment of organs inside the chest) as well as other procedures, in order to warm or cool a patient. The 3T device uses water tanks to circulate temperature controlled water through warming/cooling blankets. Although the water is contained in a closed circuit and does come into direct contact with the patient, it is possible that contaminated water may transmit bacteria through the air from the 3T devise’s exhaust vent.
Testing has found M. chimaera contamination in the water supply and production line of the 3T devices manufacturing facility. Units from this contaminated line have shipped worldwide. The FDA has provided recommendations for health care facilities as well as for patients. The full set of recommendations can be found here on the FDA’s website.
For patients the FDA recommends:
- If you have undergone cardiopulmonary bypass, be aware of the possible signs and symptoms of NTM infection. These may include:
- Difficulty breathing
- Persistent cough or cough with blood
- Redness, heat, or pus at the surgical site
- Muscle pain
- Joint pain
- Night sweats
- Weight loss
- Abdominal pain
- If you have undergone a cardiopulmonary bypass procedure and are experiencing any of the signs and symptoms of NTM infection as outlined above, contact your health care provider as soon as possible.
- If you are not currently experiencing any changes in your general health, inform your health care provider during your next wellness visit that you have undergone a cardiopulmonary bypass procedure to determine if you require further testing or monitoring for possible exposure to NTM.
The FDA is still investigating and will provide updates as appropriate.
If you or a loved one suffered injuries that you believe were caused by a Stӧckert 3T Heater-Cooler System, manufactured by Sorin Group Deustchland GmbH contact one of the experienced medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today