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

Lot Number C748 - KIT

Device Problems Particulates (1451); Sticking (1597)

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

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot c748 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for centrifuge bowl leak/break or leak centrifuge alarm.No corrective and preventive action has been initiated for complaint categories centrifuge bowl leak/break or leak centrifuge alarm.The assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation, therefore it could not be determined if the specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

Event Description

Customer called to report centrifuge leak alarm during 3rd cycle.Customer opened centrifuge cover, and stated she could not see or feel any leaked fluid.Customer said when she wiped a dry gauze around the side wall of the centrifuge chamber, she reported there was fine red dust that collected on the gauze pad.Customer reported the centrifuge bowl neck was fixed in place/will not turn.Customer aborted the treatment and manually returned fluid in kit to patient.Patient reported to be stable.Customer did not return product for investigation.

• Brand Name: THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5085738
• MDR Text Key: 26486503
• Report Number: 2523595-2015-00242
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100016
• UDI-Public: 10705030100016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Report Date: 09/01/2015

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: 08/01/2019
• Device Lot Number: C748 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1