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February 24, 2017. Category: Unsafe Medical Devices

Defective Stöckert Heater-Cooler Devices Could Put Patients At Risk

It is estimated that more than 250,000 heart bypass procedures are performed in the U.S. each year using heater-cooler devices  Unfortunately, the CDC and FDA have both issued important Health Alerts to patients, physicians, and hospitals regarding the potential risk of developing serious infection from certain heater-cooler devices commonly used during cardiac surgery.

Heater-cooler devices are important devices used during open heart surgery to keep a patient's blood and organs maintained at a specific temperature. It has been determined that some Stöckert 3T heater-cooler devices were defective and may have transmitted bacteria into patients during surgery, thus placing countless patients at risk for developing post-operative bacterial infections. New information indicates that some Stockert 3T heater-cooler devices were contaminated during the manufacturing process.  Infections caused by the contaminated heater-cooler devices can be severe, difficult to diagnose, and sometimes fatal.  

The bacteria found in the devices—Mycobacterium chimaera—is a species of nontuberculous mycobacterium (NTM) typically found in soil and water. Usually, this kind of bacteria would rarely cause illness in a healthy person. However, those who have been exposed to the bacteria during an open-heart procedure can develop non-specific symptoms slowly - possibly over the course of months or up to a year - which often makes the infection difficult for physicians to diagnose.  Special cultures must be performed to help diagnose and treat patients who might have been put at risk.  

The CDC and FDA strongly encourage patients who have undergone open heart surgery to seek medical care immediately for any symptoms of potential infection which may include symptoms such as night sweats, muscle aches, weight loss, fatigue, abdominal pain, redness at the surgical site, nausea, vomiting, or unexplained fever. The infections caused by the contaminated heater-cooler devices can be severe or potentially fatal.  The CDC has created a Health Alert Network for medical providers to help identify and inform patients who might have been put at risk and may be vulnerable to infection.

This is a very serious matter, and not one to be taken lightly.  If you or a loved one have undergone open heart surgery and later developed an infection, it is important that you consult with legal counsel that is experienced with defective medical devices.  If you have questions, do not hesitate to contact us.

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