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

Lot Number C156-KIT

Device Problems Leak/Splash (1354); Device Slipped (1584); Device Displays Incorrect Message (2591)

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

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot c156 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided.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 for complaint categories, pressure dome membrane leak and alarm #17: return pressure.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.The analysis of the returned photo is still in progress.A supplemental report will be filed when the analysis of the photo is complete.(b)(4).

Event Description

The customer called to report that the return pressure dome had "popped' off during a patient treatment.The customer reported that she was flushing the patient's return line using the needle-free injection port on the return line after receiving alarm #17: return pressure alarms.The customer stated that she was pinching the return line behind this port when the pressure dome popped off.The customer reported that the return pressure dome leaked onto the pump deck and the return pressure sensor.The customer stated that the treatment was paused when this occurred.The customer reported that she had disconnected the patient from the return line and had clamped the return tubing at both the end of the line and at the pump tubing segment between the return pressure dome and the pump tubing organizer (pto).The customer was advised to abort the treatment at this time.However, the customer stated that she wanted to continue to collect and treat the buffy coat.The customer reported that she had already lowered the whole blood processed (wbp) volume amount to what had already been collected, which was approximately 1000 ml of wbp.The customer lowered the return rate to 0 ml/min.The customer confirmed that the patient was disconnected from the return line and that there was no observable air within the pto.The customer stated that the treatment proceeded to buffy coat collection.The customer was advised that the sterility of the kit's contents could no longer be guaranteed.The customer stated that she was aware of this issue but still wanted to proceed through photoactivation and to also return the contents of both the return and treatment bags manually using a filtration set.The customer was given instructions on how to clean the pump deck and return pressure sensor following a leak.The customer was informed that if the instrument's power can be recycled and if it reboots without any issue then the instrument should be ready for the next patient treatment.At conclusion of the call, the reinfusion of the uvadex treated cells had been initiated.The patient was reported to be in stable condition.A photo was submitted for investigation.

Manufacturer Narrative

A photo was returned for analysis.A review of the photo confirmed the leak from the pressure dome.The root cause for the pressure dome leak is most likely due to the pressure dome being manipulated by the customer.The customer stated that they had pinched the line behind the pressure dome when flushing the patient's return line, and this most likely caused the pressure dome to lift.When the pressure dome lifted, it most likely caused the pressure dome membrane to detach partially from the pressure dome causing the leak.No manufacturing defects were confirmed upon review of the photo.A review of the device history record found no related nonconformances and the lot had passed all lot release testing.(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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; hampton, NJ 08827
• MDR Report Key: 5613470
• MDR Text Key: 44570312
• Report Number: 2523595-2016-00112
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/30/2016

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: 07/01/2016
• Device Lot Number: C156-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: 67 YR
• Patient Weight: 82