Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in pittsburgh, pennsylvania.An adverse event was reported in which the subject experienced thrombocytopenia after hemolung 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.The alarms observed were in response to the controller behaving as intended.Clinical and technical support were provided and controller switches were performed accordingly without issue.Therapy was provided as intended.No capa was opened because of this event.Thrombocytopenia is a known possible complication associated with use of extracorporeal therapy.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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