The model and serial number are unknown.This information will be provided in a supplemental report if made available.Mfg date: 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) manufactures the heater-cooler system 3t.It is not known where the incident occurred.This medwatch report is being filed on behalf of livanova (b)(4).At this time, it is unknown if the device utilized during surgery has tested positive for contamination, or if the use of the device is related in any way to the reported patient infection.As no device information or contact information for the facility or for the initial reporter was provided in the user medwatch report, livanova (b)(4) is unable to perform any follow-up with the customer regarding this event at this time.Due diligence was performed to ensure that there is no additional information regarding this event contained in an already existing complaint.A review of existing complaints did not identify any event that matched the description provided in the user report.No further investigation is possible.In the event of receipt of new information, a supplemental report will be provided.Device not returned.
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