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

Catalog Number CLXUSA

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module leak.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 j337 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j337 shows no trends.Trends were reviewed for complaint categories, alarm #8: blood leak? (photoactivation chamber) and photoactivation module leak.No trends were detected for these complaint categories.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #8: blood leak? (photoactivation chamber) alarm during the photoactivation phase of the procedure.The customer checked the photoactivation chamber where they noticed a leak coming from the photoactivation plate.The customer aborted the ecp treatment and manually returned residual blood from the treatment bag and return bag to the patient.The customer reported the patient was in stable condition.The customer did not return product for investigation.

Manufacturer Narrative

Corrected data: d9: device available for evaluation? yes.H3: device evaluated by manufacturer? yes.The complaint kit was returned for evaluation.The smart card was not returned; therefore, the reported alarm #8: blood leak? (photoactivation chamber) could not be verified.Examination of the returned photoactivation module verified a leak had occurred as dried blood was seen on a crack in the module.The crack runs into one of the channels of the photoactivation module.The photoactivation module was pressure tested to check for leaks and a leak was verified at the site of the crack.All cellex kits are leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the crack to the photoactivation module was present at the time of manufacture.A material trace of the photo plate halves used to build lot j337 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 of the alarm #8: blood leak? (photoactivation chamber) alarm was most likely due to the leak in the photoactivation chamber.The root cause of the photoactivation module leak was due to a crack in the plate; however, the cause for the crack 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) 2021.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 11020859
• MDR Text Key: 241778044
• Report Number: 2523595-2020-00131
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J337(17)220501
• Combination Product (y/n): Y
• 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: 01/25/2021

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: 05/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 78