CELLEX Photopheresis System 의 안전성 경고

Safety alert

2018-02-06

2018-02-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180206a.html

Medical device safety alert: therakos, inc. cellex photopheresis system the united states food and drug administration (fda) issued a letter to the health care providers regarding recent reports of venous thromboembolism (vte), including pulmonary embolism (pe), in patients who received autologous immune cell therapy with the cellex photopheresis system, manufactured by therakos, inc. the cellex photopheresis system is an extracorporeal photopheresis (ecp) device system using ultraviolet-a irradiation of extracorporeally circulating leukocyte-enriched blood for the palliative treatment of the skin manifestations of cutaneous t-cell lymphoma that is unresponsive to other forms of treatment. since 2012, the fda has received seven reports of patients experiencing pe during, or soon after, active treatment sessions (mean 1.2 days). two of these reports were associated with the death of the patient, although the link between the pe and death cannot be made with certainty. of the seven pe events, four occurred in patients known to be undergoing treatment for graft-versus-host disease (gvhd), including the two patients who died. in addition to pe, the fda has received two reports noting the diagnosis of a deep vein thrombosis (dvt) in an extremity of a patient during, or soon after, an ecp session. both of these occurred in patients undergoing treatment for gvhd. although allogeneic transplant patients who develop gvhd are known to be at increased risk for vte, the timing of the events in these reports suggests that ecp therapy may increase that risk. the fda recommends health care providers: alert patients, and clinical staff and technicians involved in ecp procedures, to the signs and symptoms of pe and dvt that can develop during or after a procedure. refer to device labeling regarding considerations for anticoagulation use with this system and use clinical judgment in adjusting an individual patient's heparin dosage. report vte events related to ecp procedures that come to their attention. for details, please refer to the fda websites: https://www.Fda.Gov/medicaldevices/safety/letterstohealthcareproviders/ucm595147.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm595476.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2018.