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

Lot Number D353 - KIT

Device Problems Leak/Splash (1354); Split (2537)

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

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot d353 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided.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 drive tube leak/break.However, corrective and preventive actions have already been initiated for drive tube leak/breaks.This assessment is based on the 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.Photo analysis is still in progress at the time of this report.A supplemental report will be filed once investigation is complete.(b)(4).

Event Description

Customer called to report drive tube leak during treatment procedure.Customer noted drive tube is intact, both bearings are still in their respective holders.However the drive tube has split in the middle.734 ml of whole blood processed.Customer stated patient is in stable condition.Customer stated they aborted the treatment and returned blood/products from the return bag only.Customer declined service as they reported no damage.Customer declined to return the kit.Customer has submitted photos for investigation.

Manufacturer Narrative

A photo analysis was conducted.Review of the customer supplied photographs confirmed the reported leak from the drive tube.Although delamination of the bearing stop cannot be confirmed based on analysis of the photo, the damage to the drive tube is consistent with historical delamination of the bearing stop.Corrective and preventive actions have been created to address drive tube surface treatment improvement prior to over-molding of the bearing stop.(b)(4).Deice not returned.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; suite 300; hampton, NJ 08827
• MDR Report Key: 5340500
• MDR Text Key: 35350798
• Report Number: 2523595-2015-00329
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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,Followup
• Report Date: 12/15/2015

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: 09/01/2017
• Device Lot Number: D353 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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 Age: 54 YR
• Patient Weight: 79