MAUDE Adverse Event Report: THERAKOS XTS PHOTOPHERESIS SYSTEM

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
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 malfunctions of the centrifuge bowl leak/break.Since these reportable malfunctions are only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f704 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f704 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, leak centrifuge alarm, centrifuge bowl leak/break.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).
Event or Problem Description
The customer had called to report a centrifuge leak alarm that occurred during buffy coat collection in the final cycle of a 4-cycle procedure on the xts instrument.The customer went on to mention that there appeared to be a few droplets blood on the centrifuge leak detector.In addition, blood droplets were reported to have dripped down from the centrifuge bowl seal onto the neck of the centrifuge bowl.The customer had aborted the procedure and did not return any blood back to the patient.The patient was said to be in stable condition and would not require any medical intervention.There was no product returned for investigation, therefore no further actions required at this time.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 7038717
• Report Number: 2523595-2017-00205
• Device Sequence Number: 2037201
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F704(17)220301
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 11/16/2017

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 58