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	03/12/2018
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.A batch record review for kit lot f901 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f901 for the reported issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and leak centrifuge alarm no trends were detected for each complaint category.A photograph analysis was conducted for this complaint.A review of the customer provided photographs show the leak centrifuge alarm on the monitor screen.The additional photographs provided show the centrifuge bowl installed onto the instrument, with no signs of a blood or liquid leak on any external surface.The origin of the leak could not be determined from the photographs.A material trace on the bowls used to build lot f901 found no related nonconformances.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl leak/break could not be determined based on the information provided.This investigation is now 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 leak centrifuge alarm was received and a leak was observed.The location of the leak was not provided.The customer aborted the procedure and did not return blood to the patient.The customer reported the patient was stable.The customer has returned photographs for investigation.

• Brand Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Common Device Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7422571
• Report Number: 2523595-2018-00057
• Device Sequence Number: 1963666
• Product Code: LNR
• UDI-Device Identifier: 20705030200010
• UDI-Public: (01)20705030200010(10)F901(17)220101
• 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
• 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: 01/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT001
• Device Lot Number: F901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial 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: 63 YR
• Patient Weight: 56