MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM,

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Hole In Material (1293)

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

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e225 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends were reviewed for complaint category tubing leak, and no trend was detected for this category.This assessment is based on the information available at the time of the investigation.At the time of this report, the returned product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.(b)(4).Device not returned.

Event Description

Tubing leak reported through email.Customer reported "hole in the recirculation pump segment" found during treatment.Operator noticed that treatment bag filled up with air at 900ml of whole blood processed (wbp).No damage or leak was found at first.Physician decided to withdraw air using a 50 ml syringe and continue.Bag filled up again, so early buffy coat was initiated at 1250 ml of wbp.During recirculation, air leak was found at recirculation pump segment.Physician decided to continue despite potential unsterility, uvadex was dosed and treatment was completed.Patient reported to be in stable condition.Kit was discarded.Customer submitted photos for evaluation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the damage to the recirculation pump tubing loop and that the treatment bag had filled up with air.The root cause for the damage to the recirculation pump tubing loop could not be determined based on the customer provided photographs.This type of tubing damage is indicative of the tubing becoming pinched by the recirculation pump.This damage to the tubing may have then introduced air into the kit and this air could have then been pulled into the treatment bag as observed by the customer.One possible cause for this type of tubing damage could be a kit installation issue.However based on the provided information we are unable to definitively confirm the root cause for this tubing damage.The device history record review did not result in any related non-conformance and this lot had passed all lot release testing.All tubing undergoes a visual inspection during manufacturing and each assembled kit must pass an air leak test before being packaged.This test is designed to identify any leaks or occlusions within the kit, and only those that pass with a 100% are released.No further action required.Based on the investigation of the photos, the complaint category for this complaint has been changed to air leak from tubing leak as no blood leak was confirmed based on the photos.Trends were reviewed for complaint category, air leak.No trends were detected for this complaint category.This investigation is now complete.(b)(4).Device not returned to manufacturer.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM,
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM,
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• 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: 6301078
• MDR Text Key: 66775882
• Report Number: 2523595-2017-00020
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/31/2017

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: 11/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• 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 Weight: 68