Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in louisville, kentucky.Alung technologies, inc.Received a report of a patient experiencing thrombocytopenia during therapy.Therapy was provided as intended.Medical intervention was required by changing the medication administered from heparin to argatroban.The data log was received and reviewed by clinical and software engineering staff.The co2 removal and blood flow graphs show that therapy was provided as intended.As indicated within this case, therapy was ended due to a probable circuit occlusion.Patient therapy was already planned to end.No capa was opened because of this event.Thrombocytopenia is a known potential complication 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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