Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Event outcome was patient death.Alung technologies, inc.Received a report of a patient experiencing cardiopulmonary arrest secondary to end-stage copd.Patient initially did well with bipap and hemolung therapy.Eventually began to decompensate with complications of refractory hypoxemia and thrombocytopenia.Patient was made dnr/dni.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.During hemolung therapy, a 102 error occurred in which the o2 sensor value was greater than 24%.The controller software operated as intended by stopping the pump.Technical support was provided to the clinical staff in which they power cycled device and chose to continue the hemolung therapy at their discretion.No abnormalities were noted within the co2 removal and blood flow graphs.Hemolung therapy was provided as intended.In this case, cardiopulmonary arrest occurred secondary to end-stage copd.The patient was made dnr/dni.Review of the controller data log shows that hemolung therapy was provided as intended.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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