MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e354 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e354 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.At the time of this report, the kit still has not been received, the returned product evaluation has yet to be completed.A supplemental report will be filed when the kit has been received and the analysis of the kit, and photos is complete.(b)(4).Device not returned to manufacturer.

Event Description

Customer called to report there was a blood leak inside of the pump tubing organizer (pto).Customer noted blood was leaking from the yellow tubing coming from the drive tube into pump organizer.Customer was advised to abort the treatment, however customer opted to end the procedure to return blood/products to the patient.Procedure was performed in double needle mode.Customer stated patient was stable.Customer stated there were no alarms prior to noticing the leak.Customer stated physician has been informed of the blood leak, and return of the blood to the patient.Customer stated all blood was contained within the pump tubing organizer.Customer will return kit for investigation, and will also submit photos for evaluation.

Manufacturer Narrative

The pump tubing organizer (pto), and photos were returned for analysis.Examination of the returned pto found dried blood in the joint between the 'y' and the treatment bag inlet line.A pressure test was then performed and there were no signs of a leak.No damage was found on the tubing or the y connector; however, per the provided photo, the leak was most likely from the bond joint between the two components.The exact location of the leak could not be found, hence a root cause for the leak could not be determined.Investigation completed.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; po box 9001; hampton, NJ 08827
• MDR Report Key: 6284115
• MDR Text Key: 66228981
• Report Number: 2523595-2017-00019
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E354(17)180901
• 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: 01/27/2017

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: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E354
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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: 62 YR
• Patient Weight: 59