The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the calcium that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No service was requested by the customer for this adverse event.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since (b)(4) 2016.As part of the review, it was determined that the instrument's last service was on 10-jan-2018.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Trends were reviewed for complaint categories, increased blood pressure and hypocalcemia.No trends were detected for these complaint categories.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.Adverse event terms: hypertension and other: hypocalcemia.(b)(4).
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The customer called to report that the patient experienced hypertension and hypocalcemia during a treatment procedure.The customer stated that the patient experienced hypertension during the buffy coat collection phase of the treatment.The customer reported that the patient felt better as soon as the patient was able to urinate.The patient's blood pressure values for this treatment were requested but not provided by the customer.The customer also stated that the patient exhibited symptoms of hypocalcemia after the buffy coat collection phase of the treatment, and calcium was administered to the patient.The customer reported that the patient exhibited no other symptoms after receiving the calcium.The treatment was then successfully completed with the treated cells re-infused back to the patient.The customer stated that the patient was in good/safe condition at the end of the treatment.In a follow-up with the customer on (b)(6) 2018, the customer reported that the patient had an underlying condition of hypertension.The customer stated that the patient does not follow the clinician's advice related to a healthy diet, and that the patient eats and drinks more than advised.The customer reported that they also believed that the patient's hypocalcemia symptoms were due to the anticoagulant, acda (10:1 ratio), that they chose to use for this treatment.The customer stated that they administered 10ml/ 100ml saline/10 min, iv calcium to the patient when they first noticed the patient's hypocalcemia symptoms.No product was returned for investigation.
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