Stockert 3t heater-cooler
A “heater-cooler”? That sounds like a device with an identity crisis. And that may be the case. But that’s not the worst thing about the Stockert 3T heater-cooler – not by a long shot.
Potentially fatal bacterial infections are the biggest risk that has been associated with the Stockert 3T heater-cooler system.
A heater-cooler is a device commonly used during surgical procedures, and its purpose is to regulate patients’ internal temperatures.
Cardiothoracic surgeries – which are those that involve the heart and lungs – often require careful regulation of the patient’s internal temperature. Controlling the surgical temperature is an important technique for safeguarding patients’ health.
In cardiac (heart) surgeries, lowering the temperature of the heart can actually slow or pause its function. That sounds scary, but it’s actually something that surgeons sometimes need to do in order to complete their procedures with the greatest care and safety.
A heater-cooler is a device that uses heat exchangers and/or thermal blankets to regulate surgical temperatures on demand, according to the needs of the surgeon and the functionality of the patient’s internal organs.
If a heater-cooler is manufactured well and used properly, it can be a life-saving device.
Unfortunately, the Stockert 3T heater-cooler system may not be a well-manufactured device.
The Stockert 3T heater-cooler – which has been manufactured by both the British-based medical device company LivaNova PLC and the Italian medical device company Sorin Group – uses a compressor and three separate water tanks to regulate patients’ temperatures. So far, so good.
But the Stockert 3T has been linked to a number of cases of severe and potentially fatal bacterial infections.
The temperature-controlled water in the Stockert 3T heater-cooler does not come into direct contact with the patient. But the device uses an exhaust vent as part of the mechanism that regulates the water temperature, and that exhaust vent exchanges air with the operating room.
Air in operating rooms is not exactly the cleanest air.
The bacterium that the Stockert 3T heater-cooler can deliver into patients’ bodies is called Mycobacterium chimaera (M. chimaera), a nontuberculous mycobacterium (NTM) commonly found in soil and water.
This is a nasty bacterium, and it has no business being introduced into your body when your body is at its most vulnerable.
The U.S. Food and Drug Administration (FDA) has linked Mycobacterium chimaera with a number of serious health problems, which include but are not limited to:
• muscle and joint pain
• abdominal pain
• nausea and vomiting
• night sweats
• weight loss
In the very worst cases, this bacterium can cause a deep, long-lasting infection that can result in death.
In many cases, that infection can take years to develop and to cause serious harm. These infections and their causes can be difficult to detect. But the FDA has received a great many formal complaints about the Stockert 3T and other heater-cooler systems. The FDA is aware of the health risks that have been associated with these devices, and has issued a set of guidelines for their usage.
If you’ve had heart surgery, lung surgery, or esophageal surgery (all of which are classified under cardiothoracic surgery), there’s a chance that your doctors used a heater-cooler system when they operated on you – possibly the Stockert 3T heater-cooler.
But since you were unconscious during your surgery, and since you almost certainly don’t know the names of all of the specialized devices used during your procedure, you probably don’t have any idea if you have been exposed to the potential health hazards of this device.
If you’ve had heart, lung, or esophagus surgery, and have suffered from any of the health complications listed above, you may be at risk for the bacterial infections that have been linked with the Stockert 3T heater-cooler.
If you think your health is at risk, contact TheLawFirm.com today. We know all there is to know about filing lawsuits about defective medical devices, and we will advocate for your health and fair compensation every step of the way.
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