A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in london, united kingdom.A livanova field service representative was dispatched to the facility to investigate the device and could reproduce the reported error.After removing the covers of the machine it was visible that the stirrer motor (pump 1) was not rotating as expected.In order to solve the issue, stirrer motor and distribution board were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Complaint database review revealed that unit was installed in 2017 and no further similar issues were reported.Based on all the gathered information, it cannot be ruled out that a failure of the stirrer motor, no longer able to turn freely, have resulted in a problem with the boards too.In deeper details, it can be assumed that a (partially) blocked motor, likely due to wear of the bearing or corrosion/degradation or also environmental conditions, as water infiltration, humidity, condensation or high temperatures, led the machine to request for an electrical power overload, which could have resulted in an over-current that ultimately damaged the board.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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