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	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as an mdr due to the reportable malfunction pto leak.Since this reportable malfunction is associated only with the kit, this mdr will be only against the kit.A batch record review for kit lot p320 was conducted.There were no non-conformances associated with this complaint.This lot met all release requirements.A review of kit lot p320 shows no trends.Trends were reviewed for complaint categories alarm #57: return pump (#3) error and pto leak.No trends were detected for these complaint categories.An investigation has been performed based only on the customer complaint description; neither the kit nor any kit components were returned.No photographs were provided for evaluation either.The pto leak could not be verified, and therefore, neither could the root cause.No further action is required at this time; this investigation is now complete.(b)(6) jm 18/may/2026.
Event or Problem Description
The customer contacted therakos to report that an alarm # 57: return pump (#3) error and a pump tubing organizer (pto) leak occurred with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.Approximately 1050 ml of whole blood had been processed.The ecp treatment was aborted, and residual blood was not returned to the patient.Treatment was starting elutriation when alarm #57: return pump (#3) error occurred.The customer reset the alarm and noted the pump was not turning properly when the pump tubing inside the organizer broke.The customer was not able to clearly articulate which section broke.No pictures were taken, and the kit was discarded.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: 25211879
• Report Number: 3036773437-2026-00047
• Device Sequence Number: 21465859
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P320(17)270401
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 05/18/2026

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: P320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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: 14 YR
• Patient Sex: Female
• Patient Weight: 37 KG