Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).Based on current level of information, the reported adverse event was solely due to an user error in powering off the centrifugal pump and is not related to any device malfunction.In addition, based on provided information, it is very likely that the patient lost consciousness due to the kink of cannula impacting return flows and not to the power off of the pump which reportedly was immediately turned back on by the user.A review of complaints database revealed that no further events of users accidentally switching off the centrifugal pump system have been reported so far, indicating that there is no trend or pattern for this type of event and that there is no relationship between the reported incident and livanova equipment.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|