MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED Cellex Photopheresis System

Catalog Number	CLXSP-I
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted therakos to report they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported that they received an alarm # 8: blood leak? (photoactivation chamber) at the end of photoactivation.The customer confirmed a crack within the photoactivation module, causing a leak.The ecp treatment was aborted and the residual blood within the kit was not returned to the patient.The customer reported the patient was in stable condition.No product was returned for evaluation.
Additional 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 p178 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot p178 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.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).H.M.27 aug 2026.

• Brand Name: Cellex Photopheresis System
• Common Device Name: Cellex Photopheresis System
• Manufacturer (Section D): THERAKOS DEVELOPMENT LIMITED; blanchardstown, dublin D15 A P2D; EI D15 AP2D
• Manufacturer (Section G): Harmac Medical Products, Inc.; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: brian stimson ; 1170 us highway 22; bridgewater, NJ 08807 ; +1(585)233-5524
• MDR Report Key: 50474027
• Report Number: 3036773437-2026-00069
• Device Sequence Number: 10204624
• Product Code: LNR
• UDI-Device Identifier: 30705030000006
• UDI-Public: (01)30705030000006(10)P178(17)270901
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CLXSP-I
• Device Lot Number: P178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown