A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 system.The incident occurred in joliet, illinois.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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From follow-up communication, field service engineer responsible for the site clarified that no service activity has been performed since the customer did not request it, likely due to an isolated occurrence of the error.Error 442 (fault in motor controller: detection of speed set value different to actual value) can be caused by an occlusion too hard, wrong tubing, rotor blocked by foreign material or defective rotor bearing.Taking into account that the error has not come back, it can be excluded that the issue was related to defective bearings.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported, neither concerning trend has been identified.As per ifu, the user should check all cables, tubes, connectors and other accessories to make sure that they are connected correctly, are not leaking and are in perfect working order.Based on all the above, the most likely root causes of the reported event are the following:(i) occlusion too hard, (ii) wrong tubing and or/ (iii) rotor blocked by foreign material.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
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