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

Lot Number NOT PROVIDED

Device Problems Fire (1245); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

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 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
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5385946
• MDR Text Key: 36988820
• Report Number: 2523595-2016-00003
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 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
• Device Operator: Biomedical Engineer
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/22/2016
• 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 Number: 1