MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
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 f704 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f704 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 f704.Trends were reviewed for complaint categories, centrifuge bowl leak/break, occlusion system alarm.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 customer provided photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).
Event or Problem Description
The customer called to report a centrifuge bowl leak/ break that occurred during a patient treatment.At the 6th cycle of the procedure is when the incident was said to have occurred.The customer stated an occlusion system alarm sounded but it was able to be reset and procedure could continue.Then, a second occlusion system alarm sounded and the customer noticed a blood leak in the centrifuge chamber.The procedure was immediately ended with no blood or products returned back to the patient.The patient was in stable condition and not affected by the incident.The customer provided photographs to be returned for investigation.
Additional Manufacturer Narrative
The customer photographs were returned and investigated for analysis.The photographs provided confirm the centrifuge bowl leak/ break reported.However, the origin of the leak cannot be determined based on the provided photographs.A material trace on the bowls used to build lot f704 found no related non-conformances.The device history record review did not identify in any related non-conformances, and this kit lot had passed lot release testing.A definitive root cause for the reported centrifuge bowl leak could not be determined based on the complaint description and customer provided photographs.No further action is required at this time.Investigation complete.Investigation complete.(b)(4).

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 7187081
• Report Number: 2523595-2018-00013
• Device Sequence Number: 13714247
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F704(17)220301
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/21/2018

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: F704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR