G.5.The heater-cooler 16-02-80 is not distributed in the usa, and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H.4.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in italy.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This report was due on december 02, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted following restoration of the livanova systems.
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Livanova deutschland received, through a lawsuit, a report that a male patient undergone surgery on (b)(6) 2012 was found infected by mycobacterium chimaera and died on (b)(6) 2013.Heater-cooler system 3t was used during surgery.Based on current status of the investigation the alleged device issue was not confirmed yet.
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