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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2020

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 h352 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h352 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 photographs and kit with smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they were performing a blood prime when the centrifuge bowl broke.The patient was not connected at the time the incident occurred.The customer has returned photographs and the kit with smart card for investigation.

Manufacturer Narrative

The customer returned photographs and the complaint kit with smart card for investigation.A review of the data recorded on the returned smart card verified the occurrence of an alarm #7: blood leak? (centrifuge chamber) alarm after 207 ml of whole blood had been processed.The customer provided photographs verify the centrifuge bowl broke as blood splatter is seen around the centrifuge chamber and pieces of the centrifuge bowl are seen at the bottom of the centrifuge chamber.Examination of the returned kit showed the outer centrifuge bowl has separated from the bowl base.The separation occurred around the circumference of the outer bowl.The outer bowl was missing the weld joint, indicating the centrifuge bowl break occurred in the material and not at the weld joint.A material trace of the bowl assembly and its components used to build lot h352 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 cause for the alarm #7: blood leak? (centrifuge chamber) alarm was due to the centrifuge bowl break.The root cause of the centrifuge bowl break was due to a separation of the outer bowl and bowl base; 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).P.T.(b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 10165838
• MDR Text Key: 198754235
• Report Number: 2523595-2020-00064
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H352(17)210801
• 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: 07/16/2020

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: 08/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1