Patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in columbus, ohio.Medical intervention was required to prevent further patient injury.Alung technologies, inc.Receieved a report of a patient experiencing thrombocytopenia during hemolung therapy.The patient was switched from heparin to argatroban.The healthcare provider decided to discontinue hemolung therapy due to risk of anticoagulating further.According to the report the hemolung device was functioning without issue and with no alarms present.Therapy was discontinued without issue.The data log from hemolung 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.No unexpected alarms or errors occurred.Hemolung therapy was provided as intended.The returned device was evaluated for any abnormalities.There were no findings within the analysis.There were no mechanical indications that the device would have malfunctioned.Thrombocytopenia is a known possible occurrence with extracorporeal hemolung therapy.Examination of the returned disposables as well as the controller data log show 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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