Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).It was reported that the patient experienced hypotension.The hypotension was suspected to be sedation related.Norepinephrine ran for approximately 4 hours the morning after the event and sedation was off 48 hours later.The event resolved.Sedation was due to intermittent mandatory ventilation.The data log was received and reviewed by clinical and software engineering staff.The co2 removal and blood flow graphs show that therapy was provided as intended.Hypotension is a known potential complication associated with critical illness and/or use of extracorporeal therapy.Review of the data log shows that therapy was provided as intended.Alung will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung 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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