The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the compression stockings and heparin that were provided 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 16-jan-2017.As part of the review, it was determined that the instrument's last service was on 12-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, thrombosis and pulmonary embolism.No trends were detected for these complaint categories.Technical bulletin clx #29 has been created to provide customers with additional information regarding potential thromboembolic events with gvhd patients undergoing therakos¿ cellex¿ photopheresis treatments.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: thrombosis and pulmonary embolism.Mc: (b)(4).(b)(6) 01/04/2019.
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The customer reported that an extracorporeal photopheresis (ecp) patient experienced a pulmonary embolism and a lower leg thrombosis.The customer stated that the patient's last ecp treatment was on (b)(6) 2018.The customer reported that due to the patient's lung transplant rejection, the patient arrived at the ecp facility for their ecp treatment on 2 l/min of oxygen, which was provided by the transplant center.The customer reported that there were no alarms or issues during the patient's ecp treatment and the treatment was successfully completed with both blood and treated cells returned to the patient.The customer stated that the patient was in stable condition both during and after the treatment.The customer reported that the patient entered a rehabilitation facility due to their general condition about two weeks after their last ecp treatment.The customer stated that due to the patient's worsening lung function a computer tomography was performed at the rehabilitation center, which showed a pulmonary embolism.The customer reported that a deep vein thrombosis in the patient's lower leg, which was probably older, was also found.The customer stated that the patient was provided with compression stockings and subcutaneous heparin injections for their leg thrombosis.The customer did not provide any information regarding the patient's treatment for their pulmonary embolism.The customer reported that the patient was currently in stable condition.The customer stated that the patient's ecp treatments has been put on pause for the month of (b)(6) but the patient's ecp treatments will continue again in mid (b)(6) 2019.No product was returned for investigation.
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