Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in (b)(4).It was reported that the patient experienced chronic normocytic anemia during hemolung therapy.The patient's hemoglobin had been gradually down trending during admission without acute drop.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.Therapy was provided as intended.No capa was opened because of this event.Anemia is a known potential complications associated with use of extracorporeal therapy.Review of the 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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