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- The Centers for Disease Control and Prevention Heater Cooler Statement
- November 16, 2016
The Centers for Disease Control and Prevention (CDC) has informed us that Stockert 3T Heater Cooler devices manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) may have been contaminated with Mycobacterium chimaera (M. Chimaera) in the manufacturing process, and that patients for whom these devices were used during cardiac surgery may be at risk for developing infections.
Winthrop-University Hospital wishes to point out that to date, we have not identified any patients who have experienced an infection from this device following open heart surgery. However, we are working diligently to notify all patients who have undergone procedures in which this device was used.
Moreover, it is important to reassure all patients that the risk of such an infection is very low. Nevertheless, we will continue to monitor all patients post-surgery, with specific attention to any symptoms potentially related to this infection.
Symptoms of an infection may include:
- Night sweats
- Muscle aches
- Weight loss
- Unexplained fever
Some of these symptoms mimic the influenza virus. However, the onset of influenza is usually more sudden.
We understand than you and your family may have additional questions or concerns about the information you have received. To help answer them, we have established an information line at (516) 663-1380. Calls will be answered Monday through Friday from 9:00 AM – 4:00 PM for the next two weeks. Should you have any questions following that time period please call Winthrop Cardiovascular & Thoracic Surgery at 516-663-4400 and speak to one of our nurses.
We have provided educational materials from CDC to our clinical staff and physicians in the community about how to identify the signs of an infection in post-surgical patients. Even though the risk of infection is very low, even one infection is too many. Patient safety is our top priority, which is why we are taking this action to notify patients and clinicians.
We are confident that with our current practices in place we can continue to provide patients who need this device with safe, high quality care.