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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot g236 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g236 shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure and tubing leak.No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer sent an email to report a tubing leak during the treatment procedure.The customer reported a alarm #18: system pressure alarm was received at the beginning of treatment.The customer stated the alarm was reset and the treatment was completed.The customer stated when they removed the kit they noticed a leak at the location where three tubing's are connected into the drive tube component.The customer has returned photographs for investigation.

Manufacturer Narrative

Photographs were returned for evaluation.A review of the customer provided photographs verify the tubing leak as dried blood is seen on the inside of the drive tube clamp, tri-connector, and on the corresponding section of the drive tube component.The tubing in the photographs appear to be correctly connected to the tri-connector and the tri-connector appears to be properly seated against the drive tube.All finished kits are subjected to a leak test prior to packaging.A material trace of the tubing used to build kit lot g236 found no non-conformances.A device history record review did not identify any related non-conformances, deviations or unscheduled maintenance.Kit lot g236 had passed all testing prior to release.The root cause of the tubing leak could not be determined based on the available information.No manufacturing related defects were identified through this investigation.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8096504
• MDR Text Key: 129451597
• Report Number: 2523595-2018-00167
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

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: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: G236
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 11/28/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1