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

Lot Number D729-KIT

Device Problems Device Alarm System (1012); No Display/Image (1183); Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d729 was conducted.There were no nonconformances associated with this lot.The lot met 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 nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, no power and protocol: assembly or operation.No trends were detected for these complaint categories.(b)(4), report: the service technician replaced both fuses at the power cord and adjusted both the 5v and 12v power supplies.The service technician reseated both the display and control board connectors and successfully performed the system checkout procedure.The fuses are customer replacable parts however in this case the customer did not have any in stock.Since the replacement of this part is done by the customer, this specific issue is not trackable in our database.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 through the capa/continuous improvement process.(b)(4).

Event Description

This complaint was initially determined to be not reportable based on the information available at the time of awareness, however additional information was received on march 8, 2016 that has made this case now reportable.The customer called to report a loss of power without an alarm during the drawing cycle of cycle 3 of a patient treatment.The customer reported that the screen went blank and the machine powered down.The customer was able to power the instrument back on but the screen was still blank.The customer was advised that a fuse was likely blown and directed the customer on how to change the fuse.The customer stated that they did not have any spare fuses.The customer was advised on how to do a manual return per the operator's manual but the customer was not able to open the fluid logic module (flm) door.The customer was advised on strategies for opening the door but the customer reported that the door still will not open.The customer attempted to open the door for a few more minutes then finally stated that she needed to disconnect in order to take care of the patient.Service was requested.On (b)(6) 2016, the customer called to state that a service technician has not been on site yet and the instrument continues to sit with a contaminated kit stuck in the flm chamber.This information was escalated to technical services.A fda request, mw5060092, dated march 8, 2016 was received stating that " the patient was disconnected from the machine and ultimately the patient required one unit of packed rbc's." the kit was not returned for investigation.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5511189
• MDR Text Key: 41318224
• Report Number: 2523595-2016-00071
• Device Sequence Number: 1
• Product Code: LNR
• 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
• Type of Report: Initial
• Report Date: 01/11/2016

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: 08/01/2020
• Device Lot Number: D729-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Weight: 56