The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and the medical intervention of the inpatient treatment that was 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.A device service history review could not be performed as an instrument serial number was not provided.Trends were reviewed for complaint categories shortness of breath, pulmonary embolism, and infection.No trends were detected for these complaint categories.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: dyspnea, pulmonary embolism, and infection.(b)(4).
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The customer reported that an extracorporeal photopheresis (ecp) patient experienced an infection, shortness of breath, and a pulmonary embolism while undergoing ecp treatments.The customer stated that they had received an email from the patient, which stated that the patient was canceling their future ecp treatment appointments due to experiencing a pulmonary embolism on (b)(6) 2020 while in (b)(6).In their email, the patient reported that their pulmonary embolism occurred despite prophylactic lovenox (1x40mg) administration.The patient reported that on the evening of (b)(6) 2020, she began to experience dyspnea with the slightest exertion so she went to the emergency room on the morning of (b)(6) 2020.The patient stated that she was admitted to the hospital from (b)(6) 2020 for inpatient treatment of her pulmonary embolism.The patient reported that she had other risk factors for a pulmonary embolism, such as a respiratory infection in (b)(6) 2020 and being on a contraceptive pill.No product was returned for investigation.
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