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 11/01/2018

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 g327 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g327 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 smartcard and photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.(b)(6) 2018.

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer stated the treatment was performed in single needle mode and was unsure how much whole blood was processed prior to the break.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and started a new treatment.The customer discarded the kit and has returned the smartcard and photographs for investigation.

Manufacturer Narrative

The smartcard and photographs were returned for evaluation.The photographs show the drive tube component of the kit intact with both drive tube bearings still connected to the drive tube.The customer provided photographs show the outer bowl and outer bowl cover had separated completely.The outer bowl can be seen in pieces at the bottom of the centrifuge chamber confirming the centrifuge bowl break.A review of the data recorded on the smartcard verify an alarm #7: blood leak (centrifuge chamber) was received at approximately 239 ml of whole blood processed.A material trace of the drive tube, bowl assembly and its components used to build lot g327 found no related nonconformances.A device history record review did not identify any related nonconformances and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely a separation of the outer bowl and outer bowl cover.The cause of the separation 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: 8121515
• MDR Text Key: 129587824
• Report Number: 2523595-2018-00166
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G327(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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• 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: G327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR