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

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2018

Event Type  malfunction  

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.As a result, 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 and leak centrifuge 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 returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.(b)(6) 2018.

Event Description

The customer sent an email to report a centrifuge bowl leak/break during the treatment procedure.The customer indicated that a leak centrifuge alarm was received during the return phase of the first cycle due to a centrifuge bowl leak.The customer aborted the procedure and did not return blood to the patient.The customer has returned photographs for investigation.

Manufacturer Narrative

Photographs were provided by the customer for evaluation.A review of the photographs show a fine spray of blood in a narrow band around the circumference of the centrifuge chamber wall.The centrifuge bowl leak is confirmed based on the photographs.The origin of the leak could not be determined based on the photographs provided.A material trace of the bowl assembly and its components used to build lot f704 found no related non-conformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl leak/break could not be determined based on the available information.This complaint is associated with (b)(4).No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.05/30/2018.

• Brand Name: UVAR XTS PHOTOPHERESIS SYSTEM
• Type of Device: UVAR XTS PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7504631
• MDR Text Key: 108289929
• Report Number: 2523595-2018-00094
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200027
• UDI-Public: (01)20705030200027(10)F704(17)220301
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

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
• Device Operator: 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 Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1