It was reported that patient has a challenging type of cardiomyopathy, non-compacted, and given the patient's inflow cannula position, there was a concern for possible increased risk for inflow obstruction.Patient had very frequent pi events on the vad interrogation.There was no concern for thrombus in the pump at the time, powers were not elevated and his lactose dehydrogenase (ldh) was fine.Additional information stated that pump positioning was causing the pi events, and there was a decrease in speed to keep left ventricle from decompressing too much.
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Manufacturer's investigation conclusion: a direct correlation between the reported inflow conduit malpositioning and heartmate 3 lvas, serial number (b)(6) , cannot be conclusively determined through this investigation as no images were provided by the account.Review of the log file data provided by the account confirmed a low flow event; however, a specific cause cannot be conclusively determined through this investigation.The controller event log file contained data spanning from (b)(6) 2020 at 21:51:20 to (b)(6) 2020 at 13:10:19, per the timestamp.A brief low flow event was captured on (b)(6) 2020 at 11:55:47 due to the estimated flow being calculated to be below the threshold of 2.5lpm.No alarms were recorded, and the system appeared to have been operating as intended.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6) , and no further events have been reported at this time.The heartmate 3 lvas ifu outlines steps to ensure the proper placement of the pump and inflow cannula.Care should be taken to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump can also be found in the ifu.This document explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and notes that changes in patient conditions can result in low flow.The ifu describes all system alarms and the recommended actions associated with them.Speed, power, flow, and pulsatility index are also discussed in the ifu.Heartmate 3 lvas instructions for use.Speed, power, flow, and pulsatility index are addressed in section 1 of this document.Section 4 describes the pump flow display (4-13 through 4-15) and the hazard alarms (4-19 and 4-32).The ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.Section 5 outlines steps to ensure the proper placement of the pump and inflow cannula.Care should be taken to avoid orienting the inlet towards the interventricular septum as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump can also be found in this section.Section 7 describes the actions to take in the event of a low flow alarm (7-7 and 7-11).No further information was provided.The manufacturer is closing the file on this event.
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