MAUDE Adverse Event Report: THERAKOS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number	D726 - KIT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.A batch record review of kit lot d726 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The (b)(4) lot number was not provided, as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category, tubing leak.No trends were detected.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 a blood leak at the collect tubing where the collect and anticoagulant tubings come together.Customer stated there were no alarms or complications with prime or the kit installation.Customer stated the leak was visible as soon as blood passed through the collect tubing at the bifurcation of the anticoagulant and collect tubings.The customer stated they aborted the treatment, removed the kit, and started over with a new kit.Customer stated the patient was stable throughout the treatments.The customer discarded the kit.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS; west chester PA
• MDR Report Key: 5380996
• Report Number: 2523595-2016-00008
• Device Sequence Number: 218620
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 12/28/2015

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: D726 - KIT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1