MAUDE Adverse Event Report: THERAKOS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number	D724 - KIT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.A batch record review of kit lot d724 was performed.There were no non-conformances associated with this lot.This lot met release requirements.Uvadex lot # ab6688 was reviewed.No non-conformances related to the complaint were noted.This lot met release requirements.Trends were reviewed for complaint category, photoactivation module leak.No trends were detected.Analysis of the photos sent by the customer is in progress at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).
Event or Problem Description
During certification training, operator observed after treatment was ended, that a leak at the photoactivation module had occurred.When releasing the kit and opening the photo activation chamber, operator found treatment volume on the lower glass plate of the photoactivation chamber.No leak was observed during treatment.The patient was reported to be in stable condition.The treatment was performed and volume was returned to the patient before the operator became aware of the leak.
Additional Manufacturer Narrative
Photos were submitted for analysis.The complaint description states that a leak at the photo activation module was observed after treatment was ended.Based on the review of the photos the leak was confirmed as the leak was found at the left upper edge of the photoactivation plate.However, the root cause of the blood leak could not be determined from the information provided.(b)(4).Device not returned.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS; west chester PA
• MDR Report Key: 5347458
• Report Number: 2523595-2016-00002
• Device Sequence Number: 191190
• 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: Followup
• Report Date (Section B): 12/17/2015

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: D724 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2016
• Supplement 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
• Patient Age: 59 YR
• Patient Weight: 82