MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CLXUSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Nausea (1970); Rash (2033); Urticaria (2278); Anxiety (2328); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 10820761
• MDR Text Key: 217916621
• Report Number: 2523595-2020-00123
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLXUSA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 35 YR