Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).Medical intervention was used in an attempt to avoid further patient injury but the end result was death that was unlikely to be related to the use of the hemolung device.It was reported that the patient experienced shock secondary to sepsis and cardiogenic.Three hours after start of therapy, patient began to deteriorate (decreasing blood pressure).Inotropic support increased over next ten hours (to maximum).Likely cause according to clinical team is sepsis and possibly cardiogenic shock.Due to refractory hypotension clinical team made patient dnr, but organ support continued.22 hours after randomization, patient arrested and death occurred.This event led to patient death but was unlikely to be related to use of the device.No capa was opened because of this event.Shock is a known potential complication that can occur during extracorporeal therapy and in general critically ill patients.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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Alung technologies, inc.Received a report of a patient experiencing shock secondary to sepsis three hours into hemolung therapy.This was indicated by the patient beginning to deteriorate (falling blood pressure).The clinical team relayed to alung technologies, inc.That this was possibly cardiogenic shock.Inotropic support increased over the next ten hours to the maximum amount.Due to refractory hypotension the clinical team made the patient dnar but organ support continued.22 hours after the commencement of the study the patient arrested and died.
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