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

Lot Number	D722 - KIT
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This system was used for treatment.Kit lot d722 was reviewed.There were no non-conformances.This lot met all 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 and no trends were detected for complaint category fluid logic module (flm).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.
Event or Problem Description
Customer reported that the fluid logic module (flm) leaked during the manual return of blood after the procedure.Customer stated that the treatment went well without alarms or issue.After the treatment was completed, they decided to return the rest of blood from the kit manually to the patient.Customer stated that as they turned the flm upside down, they detected a leak of blood on the right side of the flm and they decided to stop returning the blood.Patient reported as stable.The customer has submitted a photo for investigation.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• MDR Report Key: 5564012
• Report Number: 2523595-2016-00088
• Device Sequence Number: 10832558
• 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
• Type of Report: Initial
• Report Date (Section B): 03/10/2016

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: 06/01/2020
• Device Lot Number: D722 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1