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

Lot Number	D728-KIT
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.A review of kit lot d728 was performed.There were no non-conformances related to this complaint.This lot met all release requirements.The uvadex lot number was not provided, since uvadex 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 photoactivation module leak and blood pump error alarm.No trend was detected for these complaint issues.Feedback from service order (b)(4) is pending.A supplemental medwatch will be submitted upon receipt of information.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).Device not returned for evaluation.
Event or Problem Description
The customer reported that a blood leak occurred on (b)(6) 2016.She reported the kit had come in a damaged packaging (smashed).The customer did not note any abnormalities of the kit during set up.The kit primed successfully.Following clarification with the customer by the clinical services specialist, it was stated that a blood pump alarm occurred at the end of the third cycle and the customer noted a leak at the bottom of the photoactivation module.Treatment was aborted.The customer has elected to not return the kit for investigation.Service has been requested.
Additional Manufacturer Narrative
Service was dispatched ((b)(4)).The unit was verified to be free from contamination and a system checkout was performed.The complaint issue was resolved with service.(b)(4).T.D.(b)(6) 2016.Device not returned to the manufacturer.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ
• MDR Report Key: 5433505
• Report Number: 2523595-2016-00023
• Device Sequence Number: 10940367
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 01/18/2016

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: 07/01/2020
• Device Lot Number: D728-KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2016
• Supplement Report FDA Received Date: 03/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 59