A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that within 15 minutes of treatment with polyflux 170h, the patient experienced chest tightness and nausea.The patient was administered dexamethasone 15 mg for the events.The dialyzer was replaced, and treatment was successfully completed.No additional information is available.
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