Product event summary: pump (b)(4) was not returned for evaluation.The reported ¿low flow¿ event was confirmed through log file analysis which revealed multiple low flow alarms that have been logged since (b)(6) 2017 and continuing through (b)(6) 2018.Of note, the site reported an inflow cannula positioning issue, which can be associated with low flows.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the available information and the risk documentation, the most likely root cause of low flows may be attributed to an inflow cannula positioning issue.If information is provided in the future, a supplemental report will be issued.
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