E1: initial reporter address: (b)(6).H10: 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.
|
It was reported during hemodialysis therapy, the patient experienced allergic reaction symptoms with a polyflux 170h set.The patient experienced chest tightness, severe cough, asthma discomfort, pain, irritability, hypotension, increased heart rate, and dizziness.The dialyzer was replaced for the different brand filter.The patient was treated with oxygen and ¿other treatments¿ (not further specified).No additional information is available.
|