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 a patient experienced vomiting, chest distress and dyspnea during treatment with one unit of polyflux 14l dialyser.Medical intervention was not reported.At the time of this report, the patient outcome was reported to have stabilized.No additional information is available.
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