MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E308 - KIT

Device Problems Break (1069); Leak/Splash (1354); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e308 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.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 drive tube leak/break, centrifuge bowl leak/break and alarm #7: blood leak? (centrifuge chamber) and no trend was detected for either of these categories.Service order (b)(4) completed: service engineer cleaned the centrifuge assembly, replaced bowl clamps and centrifuge leak detector and performed system checkout procedure successfully.This assessment is based on information available at the time of the investigation.The evaluation of the product returned by the reporter was still in progress at the time of this report.A supplemental report will be sent once investigation is complete.(b)(4).

Event Description

Customer called to report bowl break during purge air, after 143ml of whole blood processed.Customer stated the bowl came off of the platform and damaged the leak detector strip.Drive tube twisted and leaked as well.Treatment was aborted.Patient reported to be stable.Service was dispatched.The customer will return the kit, smart card, and photos for investigation.

Manufacturer Narrative

Review of the returned evidence found the outer centrifuge bowl was improperly welded.This weld issue prevented the ability to properly install the bowl into the centrifuge bowl holder.The investigation determined the cause of the improper weld was damage to a component in the outer bowl welding equipment.This damaged welding equipment was repaired under an unscheduled maintenance during manufacture of kit lot e308.However, due to the intermittent nature of the welding defects caused by the damaged welder, the maintenance event did not properly identify all parts impacted.As a result of this investigation, the bowl fit go/no-go process was improved to prevent the possibility of operator bypassing the fixture.A health hazard evaluation was completed as a result of this issue.In addition, a capa was initiated at the manufacturing site to further investigate causes of centrifuge bowl leaks/breaks.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5864452
• MDR Text Key: 52878040
• Report Number: 2523595-2016-00173
• Device Sequence Number: 1
• Product Code: LNR
• 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: 07/15/2016

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: 02/01/2018
• Device Lot Number: E308 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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: 73