Initial reporter: phone number: (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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It was reported that one hour after the start of treatment with one (1) unit of polyflux 210h, the patient complained they were not feeling well.Dialysis treatment was immediately discontinued due to the patient appearing half-conscious and looked flushed (red face).It was not reported if the extracorporeal blood was returned to the patient.It was reported that after some rest, the patient recovered and a new treatment was started with a non-baxter dialyzer.The treatment was completed without any problems and the patient was able to return home.No additional information is available.
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