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

Lot Number	D902 - KIT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This system was used for treatment.Kit lot d902 was reviewed.There were no non-conformances.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 non-conformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trends were detected for complaint category centrifuge bowl leak/break or leak centrifuge alarm.Service order feedback is still pending at the time of this report.A supplemental report will be sent once service order feedback is received.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 a leak centrifuge alarm just before collection of the buffy code (bc) in the first cycle.She also states there was an abnormal sound in the centrifuge chamber, it seemed like heating up and the glass lid was fogged.Treatment was aborted and no blood was returned to the patient.Patient is in stable condition, no further details were provided.Customer requested service, service order (so) will be dispatched.
Additional Manufacturer Narrative
Service order (b)(4) completed: service engineer replaced vacuum pump and performed system checkout procedure successfully.(b)(4).Debvice not returned.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• MDR Report Key: 5611311
• Report Number: 2523595-2016-00101
• Device Sequence Number: 23466
• 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,Followup
• Report Date (Section B): 03/30/2016

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: 03/01/2016
• Device Lot Number: D902 - KIT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 90