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 after two and half hours of therapy using a revaclear 300, the patient experienced generalized pruritus without hemodynamic changes.At the time of the event, the oxygen saturation was 100%, fio2: 21% and heart rate of 59 bpm.Ten minutes later the patient presented with sinus tachycardia 90 bpm and ¿anxious allergy¿.Treatment was stopped and administration of hydrocortisone 200 mg intravenously was provided.The patient was observed for 30 minutes.It was reported the patient was ¿feeling well¿ and left without any symptoms.No additional information is available.
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