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

Lot Number	C906 - KIT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
System was used for treatment.Kit lot c906 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for photoactivation module leak or blood pump error alarm.This assessment is based on the information available at the time of the investigation.Analysis of the photoactivation module is still in process at the time of this report.A supplemental report will be created once the investigation is complete.(b)(4).
Event or Problem Description
Customer called to report that during photoactivation, it was noticed that the photoactivation module was leaking at the upper right corner seal.Customer reported 2 blood pump alarms before this, which prompted checking the photoactivation chamber.The procedure was aborted at this time and no blood was returned to the patient.Customer reports that the leak was contained and that service would not be needed to clean the instrument.Patient was reported as stable.Customer will return product for investigation.
Additional Manufacturer Narrative
The photoactivation module was returned for analysis.The returned photoactivation module was pressure tested and bubbles came out of the plate just inside the outlet port (to the right of the port), confirming the leak.Root cause for a leak of this nature is considered manufacturing operator error during the tube bonding process.All complaints are reviewed with the manufacturing department operators and leaders to make them aware of any defects that can occur.A manufacturing corrective action was initiated to study the effects of differing solvent bond methods and the investigation was completed on 08/27/2015.Changes from this investigation were implemented on 12/18/2015.This kit lot was manufactured (09/01/2014) prior to the implementation of the manufacturing corrective action.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• MDR Report Key: 5548813
• Report Number: 2523595-2016-00084
• Device Sequence Number: 300661
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/08/2016

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: No Information
• Device Expiration Date: 12/01/2019
• Device Lot Number: C906 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 113