Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras.The incident occurred in minneapolis, minnesota.Medical intervention was required to prevent further patient injury.The data log from hemolung therapy has been retrieved and reviewed by both clinical and software engineering staff.Consistent blood flows and co2 removal were observed at the time of the event.The date log showed that two days following the event, the patient was re-cannulated and a new circuit was connected without issue.There were no abnormal user interactions identified in the data log on the reported event date.Therapy was provided as intended.No corrective action was identified for this event.Anemia is a known possible occurrence with extracorporeal hemolung therapy.Review of the controller data log show that hemolung 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 review 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.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Data log reviewed.
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