MAUDE Adverse Event Report: THERAKOS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number	D729 - KIT
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.A batch record review of kit lot d729 was performed.There were no nonconformances related to this complaint.This lot met 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 nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, system error, centrifuge bowl leak/break, leak centrifuge alarm.No trends were detected.Feedback from (b)(4), is still pending at the time of this report.A supplemental report will be filed when the information is available.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 centrifuge bowl inlet line within a couple minutes of starting the procedure.Customer reported having multiple occlusion alarms.Customer did not note if they were patient or system occlusion alarms.Customer reported having an unknown system error during prime.Customer flushed the patient port which flushed easily.Saline bolus given without issue.Customer tried to resume treatment when blood leak alarm occurred.Customer reported approximately 2ml leak.Treatment was aborted and no blood was returned to the patient.Patient was reported as stable.The customer elected not to return the kit for investigation.Customer requested service to check the instrument.(b)(4), was generated.
Additional Manufacturer Narrative
Service order (b)(4) completed: service engineer cleaned and inspected internal components and performed system checkout procedure successfully.(b)(4).

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS; hampton NJ
• MDR Report Key: 5407432
• Report Number: 2523595-2016-00018
• Device Sequence Number: 16402850
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/07/2016

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: 08/01/2020
• Device Lot Number: D729 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2016
• Supplement Report FDA Received Date: 06/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 93