MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e214 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e214 for the reported complaint issue showed no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned kit photos is still in progress.A supplemental report will be filed when the analysis of the kit photos is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a tubing leak that occurred around 180ml of whole blood processed.The customer stated that the leak came from a hole in the plasma line, which is the line that comes out from the centrifuge chamber.The customer reported that when they saw the blood on the pump deck, they aborted the treatment with no blood/products returned to the patient.The customer stated that the patient was in stable condition.The customer reported that a new kit was set up and the patient received their treatment.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak in the yellow plasma line tubing.The photos indicated a visible leak on the pump deck and the yellow plasma line tubing as the source of the leak.However, it was not clear from the photos what type of damage was present on the tubing.The root cause for the tubing leak could not be determined based on the available information.The device history review did not result in any related nonconformances and this kit lot had passed all lot release testing.A material trace of the plasma line tubing used to build this kit lot also did not find any related nonconformances.No further action required.This investigation is now complete.Device manufacture date: 09/27/2016.Device not returned to manufacturer.

• 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 ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6214836
• MDR Text Key: 63812783
• Report Number: 2523595-2016-00286
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

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: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 42 YR