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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354); Failure to Auto Stop (2938)

Patient Problem No Information (3190)

Event Date 03/05/2019

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 g375 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g375 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 approximately 227 ml of whole blood was processed and the purging air/establishing separation phase was complete when the centrifuge bowl broke.The customer aborted the procedure and did not return blood to the patient.The customer reported the patient was stable.On (b)(6) 2019, a user facility medwatch was received.According to the medwatch report additional information was provided.The customer reported following the centrifuge bowl break the base of the centrifuge bowl remained secured in the bowl holder with a piece of the centrifuge bowl still attached.The customer reported blood leaked from the centrifuge chamber onto the pump deck.The customer reported the instrument did not turn off following the bowl break and was manually turned off.The customer reported the line to the patient was immediately clamped and the procedure was aborted.The customer reported treatment was not re-administered and the instrument was cleaned and serviced the following day.The customer returned photographs, the smartcard and kit components for investigation.

Manufacturer Narrative

The complaint kit, smart card, and photographs were returned for investigation.A review of the data recorded on the smart card verifies an alarm #7: blood leak (centrifuge chamber) alarm occurred after 227 ml of whole blood had been processed.Review of the customer provided photographs confirm the centrifuge bowl break as the bowl is seen in several pieces in the centrifuge chamber.The photographs show the centrifuge bowl base is still secured in the bowl holder indicating the outer bowl had separated from the base.The centrifuge bowl base with a large piece of the bowl was the only component returned for evaluation.The section of the centrifuge bowl where the outer bowl is still connected to the base was measured for weld engagement and found to be within specification.A material trace of the bowl assembly and its components used to build lot g375 found no related non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely a break in the outer bowl material.However, the cause of the outer bowl material break 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.04/11/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8484701
• MDR Text Key: 141189879
• Report Number: 2523595-2019-00040
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G375(17)201001
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR