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).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication with the customer, livanova (b)(4) learned that the heater-cooler system 3t was positioned inside the operation theater approximately 2 meters away from the operation table.In addition, it was reported that the heater-cooler was cleaned according to the instructions for use.The reported patient infection was confirmed on samples taken form the explanted valve.Water samples of the heater-cooler system 3t were taken and no contamination was found.As the mycobacteria type associated to the infection identified in the patient is not known, and no contamination has been identified in the 3t heater-cooler used during the open heart surgery, livanova (b)(4) has no elements to state that the heater-cooler 3t system is the source for the claimed patient infection.A review of the dhr did not identify any deviations or non-conformity relevant to the reported issue.If further information pertinent to this case will be received, they will be provided in a supplemental report.Device was not returned.
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