A number of medical device lawsuits have been filed against the manufacturer of a cardiac heater-cooler used during heart surgeries.

These lawsuits alleged that patients who had the cardiac heater-cooler device used during their medical procedure developed a heart surgery infection based on the allegedly defective nature of the unit.

What is a Cardiac Heater-Cooler?

A cardiac heater-cooler is a device used to control the body temperature of patients undergoing surgery. The Sorin 3T heater-cooler is one such medical device used during cardiopulmonary bypass procedures lasting up to six hours in duration.

Heater-coolers are used to either warm or cool a patient during cardiac surgeries. Patients who have an ideal, stable body temperature as regulated by an external warming or cooling unit are more likely to have favorable surgical outcomes.

Patients may experience less bleeding and may heal more quickly when their body temperature during surgery is optimized.

Heart Surgery Infection Due to Cardiac Heater-Coolers

The method behind heart surgery infection linked with the use of the medical device was due to contamination with bacteria known as Mycobacterium abcessus.

This bacteria is a non-tuberculosis mycobacterium and was found in patients who had heart surgery where a Cardiac heater-cooler was in use in the operating room.

Infection caused by the mycobacterium related to heater-cooler use is sometimes able to be successfully treated when patients are prescribed an extended course of antibiotics. Sometimes, removal of the infected tissue and other procedures also can successfully treat the infection.

However, these treatments are not always successful and patients may ultimately die as a result of the infection.

Last July, a recall was issued for the Sorin 3T Heater-Cooler system, with the FDA stating there was a risk of “[p]otential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.”

Taking Legal Action Following Heater-Cooler Heart Surgery Infection

Medical device lawsuits against the manufacturer of the Sorin 3T Heater-Cooler allege that the device is defective and that the manufacturers were negligent and breached warranties.

Some have even alleged loss of consortium (loss of companionship with spouse) and wrongful death resulting from incurable heart surgery infection acquired during surgery where a Sorin 3T heater-cooler was used.

Patients often seek damages linked to physical and emotional pain and suffering, the costs associated with medical bills and expenses, damages for lost earnings and lost potential to earn in the future, loss of enjoyment of life and other damages.

They often seek punitive damages in order to punish the manufacturer for all of the related consequences linked to the device’s use.

If you or a loved one had heart surgery where a Sorin 3T heater-cooler device was used and subsequently developed a post-surgical infection, you may be entitled to receive legal compensation as a result of your injury.

If you qualify, attorneys who deal with heater-cooler lawsuits can review your case at no charge and can help guide you on the legal options that are available to you.