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.
|
Reportedly, ¿soon after commencement of treatment¿ using a theranova dialyzer, the patient presented lower back pain, itching and flushing sensation, and blood pressure drop.The treatment was continued after 30 minutes of recirculation.Patient outcome was not reported.No additional information is available.
|