Initial reporter facility name: (b)(6) hospital.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 approximately 20 minutes after starting treatment with a polyflux 17l, the patient experienced chest tightness, shortness of breath, and sweating.Treatment was discontinued.The patient was treated with oxygen, 50% glucose water 20ml+ calcium gluconate 2g intravenous (iv) infusion and iv infusion of dexamethasone it was reported symptoms were relieved "about 10 minutes later." no additional information is available.
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