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

Lot Number D149 - KIT

Device Problems Bent (1059); Break (1069); Fluid/Blood Leak (1250)

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

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

This system was used for treatment.Kit lot d149 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 nonconformances related to the complaint were noted.Trends were reviewed and no trends were detected for complaint category drive tube leak/break or alarm #7: blood leak? (centrifuge chamber).However, corrective and preventive actions have already been initiated to investigate drive tube leak/breaks.A photo analysis was conducted for this complaint.Review of the customer supplied photographs confirmed the reported damaged components (drive tube) and subsequent blood leak.The root cause of the reported leak is that the upper bearing stop delaminated from the drive tube and allowed the drive tube to rub against the wall of the centrifuge chamber.Corrective and preventive actions have already been initiated to investigate drive tube leak/breaks.(b)(4).

Event Description

Customer reported blood leak; soon before buffy code (bc), during rump up, the drive tube bent and got broken at upper bearing stop level.The customer reports that a leak alarm 7 was posted and that the leak detector is not damaged.The treatment has been aborted.They are cleaning the system and will restart.Patient is stable.Customer will submit photos for evaluation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5525975
• MDR Text Key: 41651020
• Report Number: 2523595-2016-00064
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2016

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: 12/01/2017
• Device Lot Number: D149 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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