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 06/22/2018

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 g316 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g316 for the reported issue 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 reported approximately 206 ml of whole blood was processed at the time the break occurred.The customer stated the centrifuge assembly continued to spin for about 15 to 20 seconds after the break occurred.The customer stated they chose to unplug the instrument in order to stop the centrifuge from spinning.The customer reported a piece of the centrifuge bowl and an o-ring escaped the centrifuge chamber through the centrifuge door.The customer aborted the procedure and did not return blood to the patient.The customer reported a new treatment was not started because the patient was emotional.The patient's condition was requested and not provided.The customer has returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit, smartcard and photographs were returned for investigation.A review of the data recorded on the returned smartcard found an alarm #7: blood leak (centrifuge chamber) alarm was received after 206 ml of whole blood was processed.The photographs provided confirm the centrifuge bowl break occurred during treatment as it is seen in pieces at the bottom of the centrifuge chamber.Examination of the returned kit found the centrifuge bowl base shattered indicating that the bowl was not secured into the bowl holder.If the four tabs were effectively locked into the bowl holder, the bowl base would have remained intact and locked into the bowl holder upon discovery of the bowl break.Further inspection of the returned centrifuge bowl did not identify any issues with the four locking tabs or weld.The investigation determined the centrifuge bowl fully dislodged from the bowl holder and broke upon impacting the centrifuge chamber.A material trace of the bowl assembly and its components used to build lot g316 found no related non-conformances.A retain for kit lot g316 was inspected, and the weld engagement of the centrifuge bowl was determined to be within specification.The investigation determined the cause of the centrifuge bowl leak/break was the centrifuge bowl becoming dislodged from the bowl holder.However, the cause of the bowl dislodgement could not be determined based on the available information.No manufacturing related defects were identified through this investigation.No further action is required at this time.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
• MDR Report Key: 7705383
• MDR Text Key: 114728654
• Report Number: 2523595-2018-00114
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G316(17)200201
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 80