Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Through review of the final clinical study adverse event listings, it was reported that a patient experienced difficulty synchronizing with ventilator, requiring high amounts of sedatives.As no further notification was received regarding this adverse event, no further information is available.No capa was opened because of this event.The hemolung does not interact with the ventilator.The desynchrony is a patient/ventilator interaction that hemolung does not play a role in.Alung technologies, inc.Will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung technologies, inc.Complaints, which identified that the reporting decision for this complaint was not correct.This mdr is being filed retrospectively to correct the error in the reporting decision.
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