Patients notified of potential infection due to bacterial exposure during open-heart surgery at WellSpan York (Pa.) Hospital and Penn State Hershey (Pa.) Medical Center have filed a class-action lawsuit against device manufacturer LivaNova, seeking damages in excess of $5 million, according to PennLive.
In October and November 2015, WellSpan York and Hershey Medical Center notified 1,300 and 2,300 open-heart surgery patients, respectively, that they may have been exposed to harmful nontuberculosis mycobacterium linked to heater-cooler devices used to regulate temperature during the procedures. Two patients who filed the lawsuit claim that eight individuals who underwent the surgeries died due to infections that the CDC has since linked to improperly cleaned devices, according to PennLive.
In December, the FDA sent a warning letter to device manufacturer LivaNova expressing concerns about a potential design flaw in the heater-cooler machines that would enable bacteria to grow and become airborne during surgery. The patients filing the lawsuit are seeking class-action status so any patients who underwent the procedure at either hospital between Nov. 5, 2011 and Nov, 5, 2015 may participate.
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