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	11/14/2017
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, leak centrifuge alarm.No trends were detected for each complaint category.The kit and the data key was returned for investigation for this complaint.The data key was examined, and it confirmed the occurrence of the blood leak alarm that the customer reported.There was no sign of a blood leak from the centrifuge bowl during its initial inspection; however, the torque to rotate the top of the bowl was increased compared to the typical bowl.This indicated that there had been some debris in the bowl seal.The returned centrifuge bowl was shipped to the bowl supplier for further analysis.The centrifuge bowl supplier's investigation determined that there had been a blood leak at the bowl seal due to insufficient bonding between the bowl body and the ceramic seal.The poor bonding between the two components resulted in a centrifuge bowl leak and likely contributed to the leak centrifuge alarm reported by the customer.A material trace used to build kit 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.Issue-0299 has been opened to determine if further action is required.Investigation complete.
Event or Problem Description
The customer called to report a blood leak alarm that occurred during the 6th cycle of a patient treatment.The customer stated that there were no alarms prior to the blood leak alarm.There was no blood observed in the centrifuge chamber and no blood was seen leaking from any part of the kit.The treatment was aborted and the patient was said to be in stable condition.The patient will begin a new procedure on a different instrument.The customer has returned the kit back for investigation.

• Brand Name: XTS PHOTOPHERESIS SYSTEM
• Common Device Name: XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 7251319
• Report Number: 2523595-2018-00035
• Device Sequence Number: 11009923
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F704(17)220301
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/08/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1