Patient information was not provided.The event date was not provided.This information will be provided in a supplemental report if made available.The serial number is unknown.This information will be provided in a supplemental report if made available.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).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 (b)(4) implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
|
Serial number was received (b)(4).As we received the serial number the manufacturing date could be evaluated 29.11.2012.From a follow up communication livanova (b)(4) learned that there is no known patient infection, that the heater cooler systems 3t were cleaned regularly per the instructions for use (ifu) and that the devices were placed outside the operation theatre during use.Lab test reports were requested, but not provided.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Corrective actions were initiated for the reported issue.
|