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 35 minutes after starting treatment with a polyflux 140h dialyzer, the patient experienced difficulty breathing, chest tightness and the blood pressure (bp) had increased to 176/103mmhg.Treatment was stopped and the extracorporeal blood was returned to the patient.The patient received dexamethasone 5mg and iv 20ml 50% glucose (blood glucose was measured to be 6.2mmol/l).Forty-five minutes later bp was 138/91 mmhg.The dialyzer was changed to a fb150 dialyzer.It was reported two hours and ten minutes after the events began the patient¿s symptoms were improved, bp155/12mmhg.Two hours and twenty-five minutes later treatment was completed and bp was bp155/96mmhg.No additional information is available.
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