(b)(6).The actual device was not available; however, 2 photographs of the sample was provided for evaluation.During the visual inspection of the provided photographs, no visible defect was identified.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.Should additional relevant information become available, a supplemental report will be submitted.
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A hemodialysis patient experienced an anaphylactic reaction manifested by cough, chest tightness and shortness of breath during treatment with a polyflux 170 h dialyzer.The event was reported to have occurred approximately 20 minutes into treatment.The patient was treated with dexamethasone (dose, route and frequency not reported).The blood was returned to the patient and the treatment was paused for an hour, after which symptoms were improved.The treatment was restarted using a non-baxter dialyzer with no further issues reported.No additional information is available.
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