It was reported that two and a half hours after starting treatment with a polyflux 14l dialyzer, the patient experienced chest distress.The patient was administered an unknown amount of oxygen.It was reported symptoms did not improve and treatment was discontinued 30 minutes later.At the time of this report, the patient outcome was not reported; however, it was reported the patient returned home after treatment.No additional information is available.
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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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