The customer reported that a chronic inflammatory demyelinating polyneuropathy (cidp)patient was undergoing a therapeutic plasma exchange (tpe) procedure.During the procedure, the patient's blood pressure decreased to 108/65mmhg and the patient's eye suddenly rolled back into his head, his skin appeared rigid and he developed sweating.The rn paused the procedure and contacted the rapid response team.The rapid response team administered a fluid bolus to the patient via iv.The operator stopped and disconnected the patient.The patient is reported in stable condition.The customer declined to provide patient identifier (id).The tpe set is not available for return because it was discarded by the customer.
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This report is being filed to provide additional information.Investigation: the disposable set was not available for return.A device history record review was performed and no issues were found that could have been related to the report of the patient reaction.This patient experienced a similar reaction on (b)(6) 2018 documented in mdr 1722028-2018-00115.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged vasovagal reaction include but are not limited to patient disease state and/or patient sensitivity to the procedure.
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