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	08/08/2017
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 of the tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot d905 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot d905 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories empty a/c alarm, tubing leak.No trends were detected for each complaint category.The assessment is based on the information available at the time of 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
Customer called to report that halfway through photo activation an empty a/c alarm sounded and that is when a leak in the tubing was observed.The leak was reported to be in the line where the hematocrit sensor is placed.The procedure was aborted and no fluids were returned to the patient.There will be no product returned for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 6841795
• Report Number: 2523595-2017-00167
• Device Sequence Number: 10794239
• Product Code: LNR
• UDI-Device Identifier: 20705030200010
• UDI-Public: (01)20705030200010(10)D905(17)201001
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/05/2017

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: 10/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: XT001
• Device Lot Number: D905
• 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: 08/08/2017
• Initial Report FDA Received Date: 09/05/2017
• 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