There was no patient involvement.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).The technician tried to rotate it manually, but without resolution.In order to fix the issue, he replaced the patient 1 pump.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Based on investigation for similar events, the issue is more likely associated to the motor bearing damaged by the corrosion, which consequently does not allow the motor shaft to rotate.Possible causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
|