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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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 g340 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g340 shows no trends.Trends were reviewed for complaint category, centrifuge bowl 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 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 centrifuge bowl leak/break during the treatment procedure.The customer stated after the procedure was completed they opened the centrifuge chamber door and noticed a fine spray of red blood cells on the centrifuge chamber wall.The customer stated the patient was stable.The customer has returned the kit and photographs for investigation.

Manufacturer Narrative

The centrifuge bowl, drive tube, and customer provided photographs were returned for investigation.The photographs provided by the customer show a fine mist of blood residue on the walls of the centrifuge chamber and centrifuge bowl holder confirming the centrifuge bowl leak.Additionally there is residue seen in the area below the centrifuge chamber door in the pump deck area.The centrifuge bowl and drive tube components were received intact.The centrifuge bowl and drive tube component of the kit were pressurized and no leaks or loss of pressure was observed.The centrifuge bowl and drive tube were installed onto a test instrument for dynamic testing.The centrifuge was spun at 1000 rpm for 5 minutes, then raised to 2400 rpm for 12 minutes.The centrifuge leak sensor did not indicate any leaks during testing.The centrifuge chamber of the test instrument was inspected after testing and found no residue or leaks on the centrifuge walls.The centrifuge bowl was inspected after testing and found signs of a potential leak path between the bottom of the outer bowl and the base at the joint between the two components.Small vertical cracks were observed in the area of the outer bowl and base joint which resulted in the leak observed at the customer site.The root cause of the small vertical cracks could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.01/10/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8034942
• MDR Text Key: 127907044
• Report Number: 2523595-2018-00161
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G340(17)200601
• 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: 01/10/2019

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: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1