This report is being filed to provide additional information in b.6 and h.10.Lot number and expiry information are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not indicate a root cause for the reported citrate reaction of the patient.The system operated as intended and the procedures were run within standard operating limits (i.E., not in ¿caution status¿).There were no signals or alarms in the dlog that would indicate any issues in the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.Investigation is in process.A follow-up report will be provided.
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This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not indicate a root cause for the reported citrate reaction of the patient.The system operated as intended and the procedures were run within standard operating limits (i.E., not in ¿caution status¿).There were no signals or alarms in the dlog that would indicate any issues in the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Root cause: review of the run data file did not indicate a root cause for the reported citrate reaction of the donor.The system operated as intended and the procedures were run within standard operating limits (i.E., not in ¿caution status¿).There were no signals or alarms in the dlog that would indicate any issues in the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.A root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined.Citrate reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by donor physiology, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.
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