This patient information was not provided.Alung technologies, inc manufactures the hemolung ras and catheter.The incident occurred in (b)(4).Through review of the final clinical study adverse event listings, it was reported that a patient experienced extensive or insufficient co2 removal.As no further notification was received regarding this adverse event, no further information is available.There are many factors that can affect the amount of co2 removal during therapy.Without any further details available, no further investigation or determinations can be made.No capa was opened because of this event.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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