A woman has filed a lawsuit against the manufacturers of a heater cooler unit, the Sorin 3T Heater-Cooler System, on behalf of her loved one who allegedly suffered a bacterial infection during an orthotopic heart transplant and later died.

Plaintiff Elizabeth D. files her heater cooler unit lawsuit on behalf of Thomas D. in Florida federal court.

The defendants and manufacturers facing the lawsuit are LivaNova PLC, a foreign corporation headquartered in London, and its subsidiaries Sorin Group Deutschland GMBH and Sorin Group USA, Inc.,

According to the heater cooler unit lawsuit, Thomas D. had been initially admitted to Bayfront Health on Sept. 19, 2013, for a placement of a wound VAC device, and had undergone approximately three months of wound VAC treatment along with IV antibiotic treatment.

The complaint explains that in October 2013, however, his wound culture had in fact “returned as positive and he was diagnosed with an M. abscessus infection.” In February 2017, Thomas D. later received a letter from Bayfront Health alleging that “he had been exposed to Mycobacterium chimaera via the hospital’s heater-cooler devices during open heart surgeries.”

The heater-cooler lawsuit alleges that due to the defendant’s negligence, Thomas D. acquired an M. abscessus infection. The result of this infection required him to undergo other painful treatment and medical procedures.

In February 2017, Bayfront Health had contacted all patients who had underwent open-heart cardiac surgeries and advised that through the Sorin 3T Heater-Cooler System, they had been exposed to a “rare and potentially fatal bacteria.”

The current bacterial infection stemming from the heater cooler unit is M. abscessus. It is a subspecies of NTM, or nontuberculous mycobacterium. The strain occurs naturally in the environment and rarely causes illness. However, when contracted through a heater cooler unit, the patient’s open chest cavities and organs become directly exposed and suffer from severe and increased unique risks of the bacterial strain.

The heater cooler unit, or Sorin 3T Heater-Cooler System, is used to regulate body temperature during open heart surgery or any invasive surgical heart procedure. It is particularly important as it helps keep blood flow well circulated and helps keeps the body’s organs at a safe temperature.

The heater cooler unit works by storing water in a tank, and this tank can either increase or decrease a patient’s body temperature by keeping the water at a specific temperature. Investigators believe that if the device is improperly cleaned out or not cleaned out at all, the water inside the device can become contaminated. This contamination can then cause the contraction of the bacterial strain as bacteria can then colonize in the device. This can then lead to bacterial infections contracted during open heart surgeries, as suffered by Thomas D.

According to the heater cooler unit lawsuit, the CDC, or Centers for Disease Control and Prevention, issued an Interim Practical Guidance communication to medical providers and healthcare departments. It had advised of the risks involved in using the heater cooler unit and advised of the probability that patients have in contracting NTM infections during invasive procedures.

Moreover, the heater cooler unit lawsuit maintains that of the Medical Device Reports, or MDR’s that the U.S. Food and Drug Administration has received, approximately 90% of those reports between January 2010 and February 2016 referred to NTM patient infection and heater cooler device contamination of the 3T system.

The Heater Cooler Unit Lawsuit is Case No. 2:17-cv-00323-UA-CM, in the U.S. District Court for the District of Florida, Fort Myers Division.