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

Lot Number	D722-KIT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.A review of kit lot d722 was performed.There were no non-conformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided.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 complaint category flm 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
The customer reported a leak in the fluid logic module (flm), or close-by, during manual blood return.The patient was disconnected from the instrument at the time and reported to be stable and in good condition.The customer stated that they routinely elect to perform manual return of residual blood, after disconnecting the patient from the instrument, due to their patient population.There were no issues or alarms during the procedure.No additional blood was returned after the leak was discovered.No product will be returned as the kit was discarded.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• MDR Report Key: 5340407
• Report Number: 2523595-2015-00320
• Device Sequence Number: 971159
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Report Date (Section B): 12/10/2015

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: 06/01/2020
• Device Lot Number: D722-KIT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1