Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(6).An adverse event was reported in which the subject experienced thrombocytopenia.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 observed cs10 co2 sensor failure error appears to have been a hardware failure and the controller operated accordingly.Therapy was switched to the backup controller without issue.Therapy was provided as intended.No capa was opened because of this event.Thrombocytopenia is a known potential 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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