Sorin 3T Heater-Cooler Device Lawyer

Modern medicine is dependent upon technologically advanced devices to help improve the health of patients. It is expected that these products will be designed, manufactured and distributed with patient safety as the top priority. Unfortunately, many products, including the Sorin 3T Heater-Cooler Device fail to meet these safety standards for one reason or another.

If you or a loved one suffer from an injury caused by this device, a Sorin 3T Heater-Cooler Device lawyer could file a lawsuit on your behalf. You may be able to recover money to pay for your damages.

What is a Sorin 3T Heater-Cooler Device?

The Sorin 3T Heater-Cooler Device is a machine used to change the temperature of a patient’s body by warming or cooling their blood as it is circulated through a heart-lung machine. It is used during cardiopulmonary bypass surgery.

Device Warnings and Recalls

When a device manufacturer refuses to issue a voluntary recall, the United States Food and Drug Administration (FDA) can step in and issue their own recall as per 21 CFR 810. In 2015, the FDA issued a national safety bulletin about heater-cooler devices and their link to several nontuberculous mycobacterial (NTM) infections in patients.

In June of 2016, the FDA issued a specific warning about the Sorin 3T Heater-Cooler Device as it was linked to NTM infections in patients who had recently had open-chest cardiac surgery.

Water in the circuits of this device never directly contacts the patient. However, contaminated water can potentially get into other parts of the device and transmit NTM bacteria in the air. The bacteria is then free to travel through the air and the device’s exhaust system, into the environment and then to the patient.

NTM infections are rare and have a long latency phase, sometimes making them difficult to diagnose. However, the mortality rate of patients with these infections is 50 percent. Many impacted patients and their families have sought help from a Sorin 3T Heater-Cooler Device attorney.

Types of Medical Product Liability Claims

Defective medical product claims can be based on devices that are defectively manufactured, have a defective design even if they were properly made, or defective marketing of the product. With Sorin 3T Heater-Cooler Devices, the liability is linked to the methods, facilities, or controls used to manufacture, pack, store, or install the devices, according to the FDA.

By 2016, the FDA had received 61 medical device reports detailing an infection that could be linked to the heater-cooler device and an additional 119 reports of contaminated devices that did not cause an infection in a patient. Injured patients could turn to Sorin 3T Heater-Cooler Device legal counsel to help settle their claim against the manufacturer of these devices.

How a Sorin 3T Heater-Cooler Device Attorney Can Help

While heater-cooler devices were designed to help improve the health and quality of life in patients undergoing heart surgery, they have the potential to cause life-threatening infections. This preventable defect can cause patients to endure longer hospital stays, higher medical bills, and pain and suffering. The manufacturers of these devices should be held liable for the damages they have caused.

You can hold them liable for your injuries with the help of a qualified attorney. For more information about your legal options or to get your case started, contact a Sorin 3T Heater-Cooler Device lawyer today.