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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

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THERAKOS CELLEX PHOTOPHERESIS SYSTEM Back to Search Results
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.
 
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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 Key10820761
MDR Text Key217916621
Report Number2523595-2020-00123
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860003
Number of Events Reported1
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 NumberCLXUSA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2020
Initial Date FDA Received11/10/2020
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 Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age35 YR
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