Patient information was not provided.Lot/serial number was not provided, so the udi and expiration date could not be determined.As lot number was not provided, manufacturing date could not be determined alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in albany, new york.An adverse event was reported in which the subject experienced bleeding at the catheter site.Heavy blood flow at the catheter insertion site.Line was no longer sutured as patient had minimal subcutaneous tissue to suture.As per the medical monitor, this event did not meet the criteria of seriousness.This event was categorized as definitely related to use of the device.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.This alarm has no correlation to bleeding for this subject.No capa was opened because of this complaint.Bleeding at catheter insertion site is a known possible occurrence with extracorporeal hemolung therapy.Review of the controller data log shows 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 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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