A.1: a.5: there was no patient involvement.G.5: the heater, cooler 16-02-80 is not distributed in the usa and it is similar to heater,cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6) belgium.Through follow-up communication, livanova learned that machine gave error 08 when switched on.Field service engineer opened the unit to check if pump could rotate freely and found out that mixer motor was completely jammed.In order to solve the issue patient bridge was dismantled and a new stirrer motor was installed.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Deep dive inspection of the replaced mixer motor highlighted that ball bearings were stuck and rusted.Therefore, due to observed bearings condition, motor reasonably started drawing too much current at start-up and thus resulted into error message occurrence.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|