MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED Cellex Photopheresis System

Catalog Number	CLXUSA
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted therakos to report they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported fluid dripping from the ac drip chamber during treatment, after 600ml of whole blood had been processed.The treatment was aborted, and the patient was reported to be stable.The customer returned a video for evaluation.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 p349 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot p349 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.Video was returned for evaluation.The complaint kit and smart card were not returned for evaluation.A review of the customer provided video confirmed a leak at the bond between the spike chamber port and the orange stripe tubing.A material trace of the drive tube assembly and its components used to build lot p349 found no related non-conformances.The device history record (dhr) review did not result in any related non-conformances.The complaint kit was not available for evaluation; therefore, the root cause of the tubing leak could not be determined.No further action required at this time.(b)(4).Oe (b)(6) 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
• MDR Report Key: 50803854
• Report Number: 3036773437-2026-00070
• Device Sequence Number: 18786925
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P349(17)271001
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: CLXUSA
• Device Lot Number: P349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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 Age: 69 YR
• Patient Sex: Female