Kim Gale  |  September 22, 2017

Category: Legal News

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heart surgeryAn infection after heart surgery resulted in a man’s untimely death, says a lawsuit filed by his widow.

Hector B. underwent surgery for a mitral valve replacement and aortocoronary double bypass in July 2013.

During the surgery, a Stockert 3T heater-cooler device maintained the temperature of his blood and internal organs. The machine uses water to control temperature, but the water is not intended to come into physical contact with the patient.

The plaintiff alleges the machine emits mist from the water that becomes airborne, allowing bacteria to enter the air and settle in the patient’s open surgical wound. The resulting infection after heart surgery can lie dormant for years.

The devices allegedly were contaminated with nontuberculous myobacterium, which can lead to serious illness or death. Manufactured in Germany, the cardiac heater-cooler unit has been linked to patient deaths in the U.S. related to infections since January 2014, according to the FDA.

Tests have concluded that the strain of bacteria found in the machines is the same as that found in environmental samples from the production and servicing facility in Germany. The bacteria can be found naturally in soil and water.

Infection after Heart Surgery Traced to Heater Cooler

Hector underwent a second heart procedure in December 2013, and a third heart surgery in September 2015. During the latter, a blood test proved positive for M. abscessus, which is a subspecies of nontuberculous myobacterium.

Hector received a heart transplant in February 2016. He endured more than a year of treatment with intravenous antibiotics.

Finally, in November 2016, he received a letter from the hospital where he had undergone his first open heart surgery that explained he was exposed to nontuberculous myobacterium from the heater cooler machine. Up to that point, he nor his doctors knew how he might have contracted the infection.

Infection after heart surgery first became an issue in Europe in 2011 when Stockert 3T heater cooler devices were found to be contaminated with M. chimaera, a different strain of nontuberculous bacterium.

The infection after heart surgery lawsuit alleges the manufacturer knew the devices could introduce infectious bacteria to patients, but took no steps to warn doctors or protect patients.

The plaintiff alleges the manufacturer “knew or should have known as early as 2002 that NTM (nontuberculous bacterium), or other harmful bacteria, could colonize within the 3T System and be spread to patients during surgery through the exhaust vent.”

Proper cleaning and disinfection procedures were not provided at the time of purchase, and ways to prevent the contaminated vapor from reaching the vulnerable open cavity of the patient were never explored, says the complaint regarding infection after heart surgery.

“The foreseeable risks of using the 3T System, particularly severe bacterial infection and/or death, significantly outweigh the benefits conferred upon patients using the 3T System,” contends the infection after heart surgery lawsuit, which names Sorin Group USA, Inc., Sorin Group Deutschland GbhH, and LivaNova PLC as defendants.

The Infection after Heart Surgery Lawsuit is Case No. 0:17-cv-61455-WPD in the U.S. District Court for the Southern District of Florida, Fort Lauderdale Division.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The cardiac heater-cooler attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, cardiac heater-cooler lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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