It was reported that within 55 minutes of starting dialysis treatment with a polyflux 140h, a patient experienced facial numbness, hoarseness, retching and other unspecified "strong symptoms".The patient was treated with dexamethasone sodium phosphate (5 gm) and 50% glucose solution (60 ml) intravenously.The patient recovered from the symptoms.No additional information is available.
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Initial reporter phone no.: (b)(6).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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