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

Model Number NOT APPLICABLE

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

Patient Problem Blood Loss (2597)

Event Date 09/05/2018

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 g331 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g331 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).(b)(6) 2018.

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer reported at approximately 205 ml of whole blood processed the bowl broke into several pieces.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit, smartcard, and photographs were returned for investigation.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.The outer bowl cover is contained in the centrifuge bowl holder indicating the centrifuge bowl was properly installed.Review of the smart card data determined that the centrifuge bowl break occurred after approximately 205 ml of whole blood had been processed when an alarm #7: blood leak (centrifuge chamber) was recorded.Examination of the returned kit components verify the drive tube component was severed near the connection to the centrifuge bowl.The upper drive tube piece and broken centrifuge bowl material were not return for evaluation.A material trace of the bowl assembly and its components used to build lot g331 found no related non-conformances.A device history record review for kit lot g331 did not identify any related non-conformances, deviations or unscheduled maintenance events.This kit lot had passed all lot release testing.The centrifuge bowl break was most likely due to a separation at the weld connecting the outer bowl and outer bowl cover.However, 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.(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: 7940339
• MDR Text Key: 124984071
• Report Number: 2523595-2018-00152
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G331(17)200501
• 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: 10/25/2018

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: 05/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Age: 58 YR
• Patient Weight: 112