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

Model Number NOT APPLICABLE

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot d373 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot d373 for the reported issue shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a blood leak during the treatment procedure.The customer stated they opened the centrifuge chamber door and noticed the drive tube was broken and blood had leaked into the centrifuge chamber.The centrifuge leak detector strip had detached from the centrifuge chamber wall.The customer stated approximately 1362 ml of whole blood was processed at the time of the leak.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned a photograph for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the customer provided photograph confirm there was a blood leak from the drive tube component of the kit.The customer stated the drive tube was broken however based on the photograph provided the drive tube is still intact.Based on the photograph it appears the drive tube length was extended due to bearing stop delamination.It was observed in the photograph there is a witness mark on the centrifuge chamber wall, witness marks such as this are a known result of the drive tube impacting the wall due to the length of the drive tube being extended from delamination of the upper bearing stop.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.The root cause of the blood leak is most likely the drive tube impacted the centrifuge chamber wall due to delamination of the upper bearing stop.Corrective actions have already been initiated to address the potential root causes of drive tube delamination.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7147804
• MDR Text Key: 96227994
• Report Number: 2523595-2017-00239
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)D373(17)171201
• 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: 01/08/2018

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: 12/01/2017
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: D373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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: 64 YR