Patient information was not provided.Model and serial number are unknown.This information will be provided in a supplemental report if made available.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.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6), united states.According to paper, at the time of surgery , the heater-cooler devices had not undergone the vacuum and sealing upgrades and had not been disinfected prior to use as recommended by the manufacturer¿s ifu.The device serial number used during surgery is unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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