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	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction bag 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 p124 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot p124 shows no trends.Trends were reviewed for complaint category, bag leak.No trends were detected for this complaint category.A photograph was returned for evaluation.The kit was not returned.Review of the photograph showed blood on a wipe held below the needle-free port on the treatment bag.The actual leak site was not identified in the photograph.A material trace of the needle-free port and its components used to build lot p124 found no related non-conformances.The device history record (dhr) review did not identify any related non-conformances, deviations or equipment maintenance events.This lot passed all lot release testing.The complaint kit was not available for evaluation, therefore, the root cause for the leak at the needle-free port could not be determined based on the available information.Retraining was completed with all bonding operators on 11-feb-2026 at the manufacturing facility for tubing leaks.No further action is required at this time.This investigation is now complete.(b)(4), (b)(6) 2026.
Event or Problem Description
The customer contacted therakos to report they experienced a bag leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported the bag leak occurred during the procedure.The ecp treatment was completed, and the patient was in stable condition.The kit return was requested; however, the customer discarded the kit.The customer returned a photograph for investigation.

• 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; i.d.a. business park; castlerea roscommon, ; EI
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 24435830
• Report Number: 3036773437-2026-00020
• Device Sequence Number: 21395907
• Product Code: LNR
• UDI-Device Identifier: 00705030000005
• UDI-Public: (01)00705030000005(10)P124(17)270401
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: P124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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
• Patient Weight: 21 KG