MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling (2091)

Event Date 06/15/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the taligyl medication that was given to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the device perspective, there was no known device 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 04/30/2013.As part of the review, it was determined that the instrument's last service was on 07/28/2016.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 categories, allergic reaction, swelling, and other adverse event: itching throat.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: swelling, itching, and hypersensitivity.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a patient who exhibited the signs of an allergic reaction during a treatment procedure.The customer stated that the patient was being treated for severe mucous membrane pemphigoid.The customer reported that the patient to date had received a total of 10 treatments in a schedule of two consecutive treatment days occurring every other week.The customer stated that there had been no issues regarding the patient during those past treatments.The customer reported that during this treatment, the patient's 11th treatment, the patient experienced a mild reaction of swollen lips and an itching throat.The customer stated that the patient's symptoms occurred during the photoactivation phase of the treatment, prior to the reinfusion of any treated cells.The customer reported that the patient's symptoms were successfully treated with taligyl.The customer stated that the treatment was successfully completed and the treated cells were returned to the patient.The customer reported that the referring dermatologist informed them that a new medication, valaciclovir, was administered to the patient four days prior to this treatment cycle.The customer stated that this medication was administered to the patient in order to protect the patient from a chickenpox outbreak within the patient's family.The customer reported that they used their own solution of methoxsalen (20 mg/ml) for all their treatment procedures.No product was returned for investigation.

Manufacturer Narrative

Correction: the name of the medication that was administered to the patient when the patient's symptoms first occurred was miss- spelled in the initial medwatch for this case.The name of the medication is t.Tavegyl and not taligyl as initially reported.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6683558
• MDR Text Key: 78902449
• Report Number: 2523595-2017-00129
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR