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

Model Number NOT APPLICABLE

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

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 g337 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g337 for the reported issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and system error.No trends were detected for each complaint category.Photographs were provided by the customer 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 outer centrifuge bowl had separated from the outer bowl cover.The base of the centrifuge bowl is intact and contained in the centrifuge bowl holder.A material trace of the bowl assembly and its components used to build lot g337 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.(b)(4).

Event Description

The customer called to report a centrifuge bowl leak/break during the treatment procedure.The customer stated the break occurred during the purging air phase of the procedure.The customer stated a system error alarm was received after the bowl break occurred.The customer aborted the procedure and did not return blood to the patient.The customer has returned 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: 7915772
• MDR Text Key: 123371880
• Report Number: 2523595-2018-00145
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G337(17)200601
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 56