(b)(4).The device within the complaint was noted to have been conforming as intended during inspection of the device.As there is no non-conformances with the device, no device history records review, previous repair review, or complaint history review is required to be performed and no previous repair record is required to be attached to the complaint.On (b)(6) 2018, it was reported from (b)(6) hospital that the unit was leaking fluid during a case.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on (b)(4) 2018 and opened back of the cart and found no liquids or could not find any sort of leaking fluid.The technician then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on (b)(4) 2018.The service technician could not reproduce the reported event.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Device evaluated by external contractor.
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