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

Lot Number	D735 - KIT
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This system was used for treatment.Kit lot d735 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trends were detected for complaint category centrifuge bowl leak/break, clot observed or occlusion patient alarm.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).
Event or Problem Description
Customer called to report centrifuge blood leak alarm during treatment procedure.Customer stated that no one was hurt or splashed with blood/fluids and that the patient was stable.Customer stated that upon inspection of the parts, there was some clotting in the collect line.Customer stated that there were multiple patient occlusion alarms, which were cleared after flushing the line.Customer stated that upon opening the centrifuge lid, the fluid was leaking from the neck of the bowl.Css suggested that the customer abort the treatment and not return any blood/product to the patient.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• MDR Report Key: 5607714
• Report Number: 2523595-2016-00100
• Device Sequence Number: 186
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/28/2016

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: 09/01/2020
• Device Lot Number: D735 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2016
• Initial Report FDA Received Date: 04/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR