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

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.Kit lot f705 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f705 identified an increase in complaints associated with the centrifuge bowl leak/break complaint category.An investigation has been initiated in response to the increase of centrifuge bowl leak/break complaints observed with kit lot f705.Trends were reviewed for complaint categories centrifuge bowl leak/break, leak centrifuge alarm, and system error f404.No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).
Event or Problem Description
The customer sent an email to report a centrifuge bowl leak/break during the treatment procedure.The customer reported a system error f404 was received during treatment and a leak centrifuge alarm.The customer observed a leak from the centrifuge bowl.The customer aborted the treatment and did not return blood to the patient.The customer reported the patient was stable.The customer has returned photographs for investigation.
Additional Manufacturer Narrative
A photographic analysis was conducted for this complaint.A review of the customer provided photographs verify the leak centrifuge alarm as displayed on the instrument screen.The customer provided photographs show the centrifuge bowl inside the centrifuge chamber; however, there is no clear evidence of a blood leak from the photographs provided.During manufacturing all centrifuge bowls are tested for leaks during assembly and again leak tested as a finished product.A material trace of the centrifuge bowl used to build lot f705 did not find any non-conformances.The device history record review did not result in any related nonconformances and this kit lot had passed all lot release testing.The centrifuge bowl leak could not be confirmed therefore no root cause could be determined.This investigation is now complete.(b)(4).(b)(6) 2018.

• Brand Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Common Device Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7346640
• Report Number: 2523595-2018-00039
• Device Sequence Number: 16649961
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F705(17)220301
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: 03/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT125
• Device Lot Number: F705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 46