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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/24/2018

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 g326 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g326 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for each 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 returned kit and 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 drive tube leak/break during the treatment procedure.The customer stated they noticed specks of dried blood on the pump deck coming from under the centrifuge door.The customer proceeded to the buffy coat collection phase of the procedure at approximately 1026 ml of whole blood processed.The customer stated they completed the photoactivation phase and returned the treated cells to the patient.The return bag fluids were not returned to the patient.The customer stated when they opened the centrifuge chamber door they noted a leak on the lower drive tube bearing component.The customer stated the drive tube was intact.The customer stated the patient was stable.The customer has returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit drive tube and centrifuge bowl components were returned for investigation along with customer provided photographs.The drive tube was intact with both bearings attached and undamaged.The centrifuge bowl was examined and there were no signs of a leak.The centrifuge bowl and drive tube were pressure tested and did not result in any leaks.Additional testing was performed by installing the bowl and drive tube into a test instrument and spun to 2400 rpm for 10 minutes.The centrifuge leak sensor did not indicate any leaks and after the centrifuge stopped spinning it was inspected, resulting in no leaks.Testing did not indicate there was a leak from the centrifuge bowl or the drive tube.The customer provided photographs show residue around the inside of the centrifuge chamber and on the pump deck around the system pressure sensor.The residue is very fine dried particles that appear to be blood.The customer provided photographs verify a blood leak had occurred; however, the leak could not be replicated upon evaluation of the returned product.No manufacturing related defects were identified through this investigation.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7899730
• MDR Text Key: 121720855
• Report Number: 2523595-2018-00144
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G326(17)200401
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 98