Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in minneapolis, minnesota.Withdarwal of therapy was the outcome of the event.Through review of the expanded access form, it was noted that the patient experienced sepsis or septic shock.This led to discontinuation of therapy.The data log from therapy has been retrieved and reviewed by both clinical and software engineering staff.No abnormalities were noted within the co2 removal and blood flow graphs.Therapy was provided as intended.No capa was opened because of this event.Sepsis/septic shock is a known complication associated with use of extracorporeal therapy.There is no indication of cause of sepsis reported.Examination of the controller data log shows that therapy was provided as intended.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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