MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number	CLXUSA
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable against the kit due to the observed clot in the return line.A batch record review for kit lot p317 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot p317 shows no trends.Trends were reviewed for complaint categories alarm #17: return pressure and clot observed.No trends were detected for these complaint categories.Section 2-9, anticoagulant, of the cellex operators' manual for use with software 5.4 states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." 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 clots observed in the return line with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported alarm #17: return pressure alarms and observed blood clotting in the return line when approximately 1500 ml of whole blood had been processed.The ecp treatment was aborted, and residual blood was not returned to the patient.The patient has been reported to have been stable.No patient harm has been reported.

• 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: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 24887293
• Report Number: 3036773437-2026-00027
• Device Sequence Number: 9897283
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P317(17)270301
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 04/15/2026

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: P317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: 47 YR
• Patient Sex: Female