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

Lot Number	NOT PROVIDED
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.No kit lot number was provided as there was no kit in use.Therefore, a batch record review was not conducted.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.A review of the customer supplied photographs confirmed the issue.However, a root cause could not be determined based on the information available.Trends were reviewed for fire.No trend was detected for this complaint type.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
Therakos trained biomedical engineer, contracted by the facility to provide instrument service, called to report that the facility removed their xts instrument from service due to a burning smell.Biomed put the instrument in diagnostic mode and turned on the lamps for a while.He noted smoke and then a blue flame on the uv light cable going to p4.He was able to extinguish the flame with a reverse vacuum.The biomed was the only one present during the occurrence and stated he was not injured.The biomed requested to speak with therakos technical services regarding the repair and parts.Therakos technical service spoke with the biomed on 1/5/2016.He ordered replacement cables to repair the instrument.Therakos technical service spoke with the biomed again on 1/21/2016, he confirmed that he plans to complete the repair to this instrument himself at the end of next week.There is no request for therakos to dispatch service.Therakos service order dispatch is not needed.The customer has agreed to return pictures for investigation.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• MDR Report Key: 5385946
• Report Number: 2523595-2016-00003
• Device Sequence Number: 18906694
• 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: Biomedical Engineer
• Report Date (Section B): 01/04/2016

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: Biomedical Engineer
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1