MAUDE Adverse Event Report: THERAKOS THERAKOS XTS PHOTOPHERESIS SYSTEM

Lot Number D744 - KIT

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot d744 was reviewed.There were no non-conformances related to the complaint.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 nonconformances related to the complaint were noted.Trends were reviewed for complaint category clot observed and no trend was detected for this category.This assessment is based on information available at the time of the investigation.After multiple attempts from therakos' to obtain further information regarding this event, it is unknown as to where the clot was specifically located, hence out of the abundance of caution, this event is being reported.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned.

Event Description

Customer called to report occlusion alarms and clotting noted throughout the kit.Customer noted the anticoagulant bag is still full and it seems it may not have been dispensed into the kit.Customer aborted the kit and did not return any blood/products to the patient.Customer stated there was no kinking in the a/c tubing.Customer stated they were able to fill the drip chamber and that there were no alarms during prime.Patient reported to be stable.Customer did not return any product for investigation.

• Brand Name: THERAKOS XTS PHOTOPHERESIS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6023718
• MDR Text Key: 57695256
• Report Number: 2523595-2016-00229
• 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: 09/12/2016

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: 11/01/2020
• Device Lot Number: D744 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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