MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E342 - KIT

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Device Operates Differently Than Expected (2913)

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

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e342 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 non-conformances related to the complaint were noted.Trends were reviewed for complaint category tubing leak and no trend was detected for this category.Service order (b)(4) completed: service engineer examined instrument and found burr on front tubing guide that could cause possible damage to tubing and introduce air.Removed burr and ran system checkout test on instrument successfully.This assessment is based on the information available at the time of the investigation.At the time of this report, the product had not been received, hence, evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.(b)(4).Device not received for evaluation.

Event Description

Customer called to report that they were running a dual needle mode (dnm) procedure with no alarms.She reported starting buffy coat and the treatment bag started filling up with air.Customer reported that she thought the fluid routing valves were lined up with the tubing correctly.The customer then reported that she noticed a leak in the tubing coming from the photoactivation module.Blood leaked from the tubing onto the machine.Procedure was aborted.Patient stable.Customer requesting service for the instrument to get cleaned.Customer will return kit and will submit photos for evaluation.

Manufacturer Narrative

Photos and a video were returned for analysis.Review of the photos and video could not confirm the reported blood leak.Complaint could not be confirmed from the information provided.No manufacturing related defects were confirmed during the evaluation.Based on the analysis, no remedial actions will be conducted.Investigation completed.(b)(4).Device not returned.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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: 6109271
• MDR Text Key: 60637707
• Report Number: 2523595-2016-00253
• 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,Followup
• Report Date: 10/18/2016

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: No Information
• Device Expiration Date: 08/01/2018
• Device Lot Number: E342 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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: 51 YR
• Patient Weight: 79