Section g3: previous report inadvertently left blank.Correction: feb 11, 2021.Manufacturer's investigation conclusion: elevated power and flow events were confirmed in the evaluation of the submitted log file; however, a specific cause for the events cannot be determined through this evaluation.A direct correlation between the device and the reported neurological event could not conclusively be established through this investigation.The submitted log file contained data from (b)(6)2020 16:29:46 through 10:08:15.Elevated power events of 10.4 watts and 11.6 watts were captured on (b)(6) 2020, respectively.Flow reached 11.9 and 11.6 lpm during these events, respectively.Prior to and after these events, the pump appeared to function as intended and no other unusual alarms or events were captured.A specific cause for the changes in pump parameters could not be conclusively determined through this evaluation.At the time of the reported event, the patient was admitted awaiting orthotic heart transplant and had been having elevated powers and flows.The patient also suffered a neurological event.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient underwent a pump exchange to (b)(6) on(b)(6) 2020.(b)(6) was returned and evaluated under manufacturer report number 2916596-2020-06467.The heartmate ii lvas ifu provides an explanation of each of the pump parameters (including pump power and flow) in sections 1 "introduction" and 4 "system monitor".Section 1 of the ifu, ¿introduction¿, lists neurologic dysfunction as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Section 6, ¿patient care and management¿, also lists neurologic dysfunction as a potential late postimplant complication.Section 1 (under "explanation of parameters") explains that device power is a direct measurement of pump motor voltage and current.Changes in pump speed, flow, or physiological demand can affect pump power.Abrupt changes in power should be evaluated for cause.In addition, device flow and power generally retain a linear relationship at a given speed.However, while power is directly measured by the system controller, the reported flow is estimated, based on power.Since the flow displayed on the system controller is a calculated value, it becomes imprecise at the low and high ends of the linear power-flow relationship.Section 4 ¿system monitor¿ cautions that no single parameter is a surrogate for monitoring the clinical status of the patient, and the changes in all parameters should be considered when assessing any clinical situation.Section 4 also addresses pi events as well as potential causes.Section 6 "patient care and management" (under "pump performance monitoring") addresses assessing pump flow and explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 30sep2016.No further information was provided.The manufacturer is closing the file on this complaint.
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