Serial number is 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 (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Two devices (16s13101 and 16s13135) are currently in use at the hospital.Both deviecs were manufactured in 2012 and upgraded with vacuum and sealing configuration respectively in july 2019 and september 2019.The review of the service history records did not identify any information relevant to the reported event.Complaints database analysis revealed no previous device contamination complaints submitted by this hospital.Livanova requested additional information to the customer and reply is still pending.Based on the current level of information, the infection to the prosthesis is likely associated to the femur surgery in 2017 and a the heater-cooler device was not used for this surgery.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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