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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube 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 g335 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g335 for the reported issue shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak (centrifuge chamber).No trends were detected for each complaint category.The complaint kit and photographs were returned for analysis.The smartcard was not returned; therefore, no confirmation of the reported alarms could be made.The customer provided photographs confirm a leak occurred as splatter is seen on the centrifuge chamber walls that is consistent with a leak coming from the drive tube.The returned kit components were examined and found the drive tube was twisted just above the upper bearing stop.The drive tube component was pressure tested and confirmed a leak in the twisted portion of the drive tube.There was no damage observed on the centrifuge bowl or any other part of the drive tube components.The cause of the leak was due to the drive tube twisting instead of rotating freely.The root cause of the drive tube not rotating 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).

Event Description

The customer called to report a drive tube leak/break during the treatment procedure.The customer stated they received a pressure alarm during the purging air phase of the procedure.The customer stated the alarm was reset and the purging air phase was completed.The customer stated approximately 150 ml of whole blood was processed when they received an alarm #7: blood leak (centrifuge chamber) alarm.The customer inspected the centrifuge chamber and noted a blood leak in the chamber.The customer stated the drive tube and centrifuge bowl components were still intact.The customer stated the upper drive tube bearing came out of the upper bearing retainer clip.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.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7936268
• MDR Text Key: 123208870
• Report Number: 2523595-2018-00150
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G335(17)200501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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: G335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Age: 66 YR
• Patient Weight: 61