MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 10/02/2018

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 g326 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g326 shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and alarm #7: blood leak (centrifuge chamber).No trends were detected for each 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.

Event Description

Customer called to report a centrifuge bowl leak/break during the purging air phase of the treatment procedure.The customer stated that an alarm #7: blood leak? (centrifuge chamber) occured then the bowl broke.The customer stated that the system shut down and the treatment was aborted.The customer did not return blood to the patient.The customer stated the patient was stable.The customer returned photos and the kit for investigation.

Manufacturer Narrative

The complaint kit drive tube and centrifuge bowl components, smartcard, and customer provided photographs were returned for investigation.The customer provided photographs show the base of the bowl is still in the bowl holder.Photos indicate that the bowl was locked into the instrument platen and installed correctly.The outer bowl is largely intact, but all of the other major components of the bowl assembly are in many pieces.The drive tube has broken into two pieces.Review of the smart card data determined that the centrifuge bowl break occurred after approximately 232 ml of whole blood had been processed when an alarm #7: blood leak (centrifuge chamber) was recorded.The returned kit components were examined and the centrifuge bowl break was confirmed.The outer bowl had separated from the base completely.Examination of the returned kit components indicated the bowl break is above and into the weld between the outer bowl and the outer bowl cover.The drive tube component was examined and found to be broken in two places; one at the upper bearing stop and one at the top of the bowl connector overmold.The proper installation of the drive tube cannot be determined from the information supplied.A material trace of the bowl assembly and its components used to build lot g326 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 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).(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: 8032302
• MDR Text Key: 128211078
• Report Number: 2523595-2018-00159
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G326(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: 11/28/2018

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: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 29