The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the blood transfusion, platelet transfusion, tranexamic acid iv and novoseven 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 25-jul-2018.As part of the review, it was determined that the instrument's last service was on 17-jan-2019.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 category, gastrointestinal hemorrhage.No trends were detected for this complaint category.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: hemorrhage.(b)(4).
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The customer reported that an extracorporeal photopheresis (ecp) patient experienced peri-rectal bleeding (pr bleeding) following a treatment procedure.The customer stated that the patient had already successfully completed two cycles of ecp treatment procedures.The customer reported that the patient's last ecp treatment procedure on (b)(6) 2019 was a blood prime treatment, which used acda as the anticoagulant at a 12:1 ratio.The customer stated that four hours after successfully completing this treatment, the patient experienced massive pr bleeding.The customer reported that the physician at the hospital saw the patient, and then the patient was transfused with both blood and platelets.The customer stated that tranexamic acid iv and novoseven were also administered to the patient.The customer reported that the patient's bleeding settled after the administration of the blood products and the patient had no instances of bleeding over the weekend.The customer stated that they were unsure of the cause of the patient's bleeding.The customer reported that they were very reluctant to continue with the patient's ecp treatment procedures at the current anticoagulation ratio, but they also felt that overall the patient's ecp treatment procedures were helping the patient.The customer stated that they believed that the patient's ecp treatment procedures contributed to the patient's pr bleeding.No product was returned for investigation.
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