The parents of a minor child who developed a heart valve surgery infection allegedly due to the use of a contaminated Stockert 3T heater-cooler unit have filed a lawsuit against the machine’s manufacturer.

The Stockert 3T heater-cooler medical device is manufactured by LivaNova (formerly Sorin Group Deutschland) in Germany. The heater-cooler allegedly transmitted a rare and often deadly bacteria, Mycobacterium chimaera (M. chimaera) during the open heart surgery of Justin L., who underwent surgical replacement of a pulmonary valve in May 2017. This allegedly led to a heart valve surgery infection. 

After the hospital tested Justin and confirmed he had M. chimaera, the hospital then purportedly removed the heater-cooler from service.

Heart Valve Surgery Infection Begins

In June 2017, the lawsuit says, Justin allegedly became sick and required emergency room visits. He returned to the hospital in August 2017 where he was evaluated for continued pain, fever, and vomiting.

The parents say that on Sept. 1, 2017, hospital staff diagnosed Justin with the heart valve surgery infection known as M. chimaera. He purportedly was in the hospital every two days from Sept. 1, 2017, through Oct. 24, 2017, for continuous treatment and tests.

According to the heart valve surgery infection lawsuit, Justin was given medications that are “extremely strong and potentially toxic and are and will continue to cause problems” for Justin, including loss of hearing.

His parents have filed suit because of Justin’s prolonged pain and suffering, need for additional medical expenses and treatment, permanent scarring, mental anguish, loss of enjoyment of life, and other particulars allegedly “caused by the grossly negligent acts” of LivaNova.

Device Allegedly Tainted with Bacteria

Tests done at the production and servicing center in Germany found the same strain of M. chimaera bacteria that was found in the heater-cooler units in the United States. The bacteria grow naturally in soil and water, but it remains a mystery as to how this bacteria contaminated the heater-coolers.

The water from the heater-cooler units never physically touches a patient. The device uses water to regulate the body’s organ and blood temperature during open heart surgery. The warm water does emit a mist that enters the air. When this mist enters the air, it can settle into the open chest cavity. A mist that carries bacteria can result in that bacteria becoming sealed inside the patient once the open chest is sewn together. M. chimaera can fester for months or years before making the patient visibly sick.

According to the FDA, the heater-cooler units have been linked to patient deaths as a result of heart valve surgery infection since Jan. 2014.

The FDA’s first safety warning regarding the Stockert 3T devices was issued in October 2015. The FDA had received 32 reports of the post-heart surgery infection at that time. By June 2016, investigators determined the Stockert 3T heater-coolers were the source of the infection.

The Heart Valve Surgery Infection Lawsuit is Case No. 2:18-cv-05764-SM-MBN, in the Civil District Court for the Parish of Orleans, State of Louisiana.