MAUDE Adverse Event Report: THERAKOS, INC. UVAR XTS PHOTOPHERESIS SYSTEM

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot f704 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f704 identified an increase in complaints associated with the "centrifuge bowl leak/break" complaint category.As a result, an investigation has been initiated in response to the increase of "centrifuge bowl leak/break" complaints observed with kit lot f704.Trends were reviewed for complaint categories, centrifuge bowl leak/break, leak centrifuge alarm and damaged parts/components - centrifuge bowl outlet.No trends were detected for each complaint category.The assessment is based on the information available at the time of 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.Investigation complete.(b)(4).
Event or Problem Description
The customer sent an email to report a centrifuge bowl leak/break during the treatment procedure.The customer stated at the end of the first cycle of the procedure they received a leak centrifuge alarm.The customer aborted the procedure and did not return blood to the patient.The customer stated the centrifuge bowl had no movement between the base component and bowl outlet.The customer stated the patient would start treatment on a different instrument that same day.The customer did not return product for investigation.

• Brand Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Common Device Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7508708
• Report Number: 2523595-2018-00095
• Device Sequence Number: 232749
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F704(17)220301
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 03/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: F704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1