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

Lot Number C156 - KIT

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot c156 was performed.There were no nonconformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided, since uvadex 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 category, drive tube leak/break.No trends were identified.A corrective and preventive action was initiated for complaint category, drive tube leak/break.This assessment is based on information available at the time of the investigation.Analysis of the photographs sent by the customer is still in progress.A supplemental report will be filed when this analysis is complete.(b)(4).

Event Description

Customer called to report drive tube break "5-10 minutes into treatment".Dual needle mode.Treatment was aborted.The patient was reported to be stable and was cleared by the provider for discharge.Customer reported the base of the centrifuge bowl was still on the platform, but the bowl was shattered and the leak detector strip was damaged.Customer does not recall receiving any alarms.Customer reports that their biomed will do the repair.The customer sent pictures for investigation.

Manufacturer Narrative

Photos were returned for analysis.Review of the photos indicated that the bowl break was below the cover to bowl weld on one half and above the weld on the other half.The cover is shown still in the platen with a section of the bowl attached.The drive tube is broken just above the bowl.The cause of the leak was a bowl break.The analysis determined it is likely that the bowl break occurred first, causing a break in the drive tube.However, the cause of the bowl break could not be determined.All cover to bowl welding parameters were within the qualified ranges during manufacturing.A material trace of the two components found no nonconformances.No manufacturing defect could be identified.Review of the device history record found no related nonconformances.The complaint lot passed all lot release testing.(b)(4).Not returned.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 friontage road; suite 300; hsmpton, NJ 08827
• MDR Report Key: 5181431
• MDR Text Key: 30068798
• Report Number: 2523595-2015-00274
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: 10/09/2015

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: 10/09/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• 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: 28 YR
• Patient Weight: 83