Catalog Number CLXUSA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nausea (1970); Rash (2033); Urticaria (2278); Anxiety (2328); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
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Event Type
Injury
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Manufacturer Narrative
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The system was used for treatment.This case is reportable as a mdr as the event was considered life threatening by the authors and also due to the medical intervention of the intravenous (iv) diphenhydramine, iv hydrocortisone, oral prednisone, oral methylprednisolone, lorazepam, and hydroxyzine that were provided to the patient.Since the author associated this event with the ethylene oxide used to sterilize the cellex photopheresis kit ("kit") , this mdr will be against the kit.A kit batch record review could not be performed as the kit lot number was not provided.Trends were reviewed for complaint categories, allergic reaction, anxiety, itchy, skin redness, rash, swelling, nausea, and hives.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: hypersensitivity/allergic reaction, anxiety, skin inflammation/ irritation, rash, swelling/ edema, nausea, urticaria, and itching sensation (b)(4); s.K.(b)(6) 2020.
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Event Description
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In a journal article entitled, 'anaphylaxis following administration of extracorporeal photopheresis for cutaneous t cell lymphoma, dermatology online journal', volume 26 number 9| september 2020, authors jessica tran, lisa morris, alan vu, sampreet reddy, and madeleine duvic stated that a 35-year-old woman presented for management of biopsy-proven stage ib mycosis fungoides in 2015.Within thirty minutes of her first extracorporeal photopheresis (ecp) treatment, the patient developed a pruritic, erythematous rash and swelling of her throat.Approximately one hour following her ecp treatment, she began to experience nausea and swelling of her eyelids, lips, and uvula.A diffuse urticarial eruption was present by the next day when she presented for her second ecp treatment.The patient denied any changes in her medications or diet that may have caused this reaction.Intravenous (iv) diphenhydramine and two doses of iv hydrocortisone were immediately administered to the patient.Due to her persistent throat swelling and urticaria, the patient also received oral prednisone and was prescribed oral methylprednisolone.Three days later the patient presented to the emergency department with persistent urticaria and intense pruritus.In the emergency department, the patient was administered an additional dose of iv diphenhydramine as well as lorazepam for anxiety.The patient was discharged with oral hydroxyzine.Given the patient's anaphylactic reaction, their ecp treatments were discontinued indefinitely.The authors believed that ethylene oxide, psoralen, and heparin, may have individually or together contributed to their patient's anaphylactic reaction.Due to their previously observed acute hypersensitivity reactions to ethylene oxide with other hemodialysis procedures, the authors believed that the ethylene oxide used to sterilize the cellex photopheresis kit ("kit") was the most likely cause of their patient's anaphylactic reaction.
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Search Alerts/Recalls
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