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

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

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 g314 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g314 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 stated the break occurred after 142 ml of whole blood was processed during the establishing separation phase.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and started another treatment on a different instrument.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 142 ml of whole blood had been processed.The customer provided photographs confirm the centrifuge bowl broke during treatment and resulted in a blood leak.Examination of the returned kit found the outer centrifuge bowl cover was still intact, and all four bowl locating tabs were still attached to the cover.A horizontal crack was seen across the base of the centrifuge bowl.The amount of parent material from the outer bowl that was still attached to the base indicates that the separation was not caused by a failure in the weld between the base and outer bowl.The scuff marks and horizontal crack seen on the outside of the base of the bowl indicate the bowl dislodged from the bowl holder and impacted the centrifuge chamber causing the bowl to break.A material trace of the bowl assembly and its components used to build lot g314 found no related nonconformances.A retain for kit lot g314 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.The cause of the bowl dislodgement could not be determined based on the available information.No further action is required at this time.This investigation is now complete.A review of the device history record for kit lot g314 was performed, and one related non-conformance was identified.The root cause of the non-conformance was determined to be improper installation of the centrifuge bowl into the instrument by the manufacturing test operator.(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: 7643593
• MDR Text Key: 112868918
• Report Number: 2523595-2018-00103
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G314(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
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1