A batch record review of lot c132 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint category, other adverse event.In this case the other adverse event was numbness and tingling of the lips and mouth.There were no trends detected for this complaint category.No capa was initiated for this complaint category.Based on the medical assessment, the 42 year old female with chronic gvhd developed numbness and tingling in her lips.The patient was on acda anticoagulant.The patient was administered calcium gluconate 8.5% at 12ml per hour then to 14ml per hour then to 16ml per hour.This case is serious and related to ecp.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/ continuous improvement process.(b)(4).
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