Suit claims Bossier Parish child's infection was caused by medical device used during her heart surgery

By Mary Ann Magnell | Jul 26, 2018

A lawsuit was filed in the U.S. District Court for the Eastern District of Louisiana on July 21 against a medical device company that manufactured the Stockert 3T, a thermal regulator used during cardiopulmonary procedures in order to control patients’ body temperatures.

NEW ORLEANS – The parents of a Bossier Parish girl recently filed a civil suit in the U.S. District Court for the Eastern District of Louisiana against a medical device company that manufactured the Stockert 3T, a thermal regulator used during cardiopulmonary procedures in order to control patients’ body temperatures. 

The 19-page damage suit was filed on behalf of the minor child by her parents, Heather and Joseph Stewart, against Livanova PLC and Sorin Group USA Inc.

The minor, referred to E.S., had open-heart surgery in July 2017 at Louisiana Children’s Medical Center (LCMC) in New Orleans with the Stockert 3T device being used during the procedure, the suit said. The child has since been treated for mycobacterium abscesses and infection, the suit said. 

The suit claims the defendants could have taken steps to ensure that the girl and other patients similarly affected “would not have suffered damages from infection.” 

The device, which was manufactured in Germany and approved for use by the FDA in 2006 for use in operations that lasted six hours or longer, was found to have contamination issues and posed a risk of mycobacterium infections if it was not properly cleaned and disinfected. 

In 2014, Sorin Group filed a MAUDE Adverse Event Report with the FDA, the filing said. Later that year, Sorin’s facility risk manager reported that 15 patients had tested positive for “atypical mycobacterium infection.” Out of the 15 patients, four patients died. 

The manufacturer sent out several Field Safety Notices, warning letters and notifications between 2014 and 2016 in both Europe and the United States after the discovery of the device’s susceptibility to the bacteria, the filing said. In April 2016, the FDA “alerted health care facilities that if they purchased and used the 3T prior to September 2014, they must ‘be aware the units may have shipped from the factory contaminated with M. chimaera.’”  

Additional notices were sent out after the discovery that “existing disinfection procedures would not be sufficient to reduce the risk of bacterial contamination of a heater-cooler device if it had not been properly maintained for a long period of time, thus allow a biofilm to grow in the water circuit,” the filing said.

A Class II recall of the Stockert 3T was issued on March 17, 2016, which covered 1,125 units. According to the court document, the Centers for Disease Control issued a press release on October 13, 2016, warning hospitals about the risk of mycobacterium infections when using the Stockert 3T.

According to the court documents, the defendants are liable to the plaintiffs for violations of the Louisiana Products Liability Act for their actions/inactions in their failure to warn of the dangers of the device’s use, failure to ensure safe use of the device, inadequate design, and its failure to perform in a manner that did not cause infection. 

Additionally, the plaintiffs are suing for unspecified damages for claims of prolonged pain and suffering, permanent scarring, mental anguish and permanent impairment that were “directly and proximately caused by the negligent acts and/or omissions of the defendant.” 

 U.S. District Court for the Eastern District of Louisiana, Case No. 18-cv-6891

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