MAUDE Adverse Event Report: THERAKOS, INC. UVAR XTS PHOTOPHERESIS SYSTEM

Model Number	NOT APPLICABLE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
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 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 of kit lot f705 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f705 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, leak centrifuge alarm, centrifuge bowl leak/break, and system error f183: centrifuge speed too slow.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.
Event or Problem Description
The customer called to report a centrifuge bowl leak/break during a treatment procedure.The customer indicated that a centrifuge leak alarm occurred during buffy coat collection of the final cycle (5 of 5 cycles).The customer attempted to clear the leak alarm by cycling the power of the instrument; however, a system error f183 alarm subsequently occurred.The customer opened the centrifuge chamber door to investigate the alarms and observed a small leak (less than 10 ml of blood) from the seals in the neck of the centrifuge bowl.The treatment was aborted and no blood or fluids were returned to the patient.The patient was reported to have been in stable condition before, during, and after the blood leak.The patient was discharged to home and was scheduled to return for ecp treatment on (b)(6) 2017.No product was returned 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: 7043224
• Report Number: 2523595-2017-00214
• Device Sequence Number: 2145032
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F705(17)220301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/17/2017

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: F705
• 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: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 67