A new heater cooler lawsuit has been filed against the LivaNova Company and its affiliates in U.S. District Court.

Plaintiffs Kuo C. and Hsue C. are a married couple from Raleigh, N.C. They allege Hsue developed a dangerous postsurgical infection due to a contaminated surgical device made by LivaNova.

Defendant LivaNova is a worldwide corporation specializing in medical devices geared toward the treatment of cardiac issues. LivaNova manufactures the Sorin 3T heater cooler device. This device is used in open chest surgeries such as heart bypass to stabilize the body’s core temperature.

The Plaintiff’s Story

According to this heater cooler lawsuit, Hsue developed an M. Abscessus infection soon after a cardiac surgery done in January 2015. The couple alleges this infection was the result of a contaminated Sorin 3T heater cooler device used during her surgery to control her body’s temperature.

The couple claims Hsue had to undergo extensive and painful treatments to address this infection. She says she has suffered grave physical and emotional pain.

The couple is bringing the following actions against the defendants in this heater cooler lawsuit:

Counts One & Two—Negligence, Design Defect; Counts Three & Four—Negligence, Manufacturing Defect; Counts Five & Six—Negligence, Warnings Defect; Counts Seven & Eight—Breach of Implied Warranty of Merchantability; and Counts Nine & Ten—Negligent Misrepresentation.

The plaintiffs are asking for a trial by jury with a favorable decision on their behalf. They hope for the assessment of compensatory and punitive damages in this heater cooler lawsuit along with the return of attorney and court fees.

FDA Warning

The U.S. Food and Drug Administration (FDA), according to the legal narrative of the heater cooler lawsuit, sent out an urgent message in the early summer of 2016 to medical professionals and the public.

This message concerned several infections linked to use of the Sorin 3T heater cooler during cardiovascular surgeries. The infections were caused by a bacterium ordinarily harmless, save for the fact it was introduced inadvertently when the patient’s chest was incised.

Introduced in this manner, M. Abscessus incubates for a varied amount of time that can be short or extend upwards of six years from the date of the chest surgery. The end consequence of the resultant active infection can be systemic or localized to the heart area with a condition called endocarditis.

The symptoms of this infection resemble the flu with joint or muscle pain, fever, fatigue, and possible night sweats. Once the flu is eliminated as a cause, a complete laboratory workup can take eight weeks to process.

How Does a Heater Cooler Device Work?

The Sorin 3T heater cooler works to sustain body temperature during invasive chest surgeries by circulating water through a heat exchanger. The patient’s blood is pumped into a separate chamber near the exchanger, allowing for warming of the blood.

The mechanism of infection is believe to be due to aerolization of vapor containing M. Abscessus through the heater cooler’s exhaust system. This vapor would break into the sterile field of the operating room due to its proximity during surgery.

The Heater Cooler Lawsuit is Case No. 1:18-cv-00012 in U.S. District Court for the Middle District of North Carolina, Durham Division.