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	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted therakos to report a pressure dome leak that occurred with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.Less than approximately 100 ml of whole blood had been processed.The ecp treatment was aborted early, and residual blood was not returned to the patient.The customer also described blood getting into the pinhole of the transducer and into the deck.The customer has not returned any product or product components, nor any photographs, for evaluation.The patient has been reported to have been stable.No patient harm has been reported.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as an mdr due to the reportable malfunction pressure dome 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 p327 was conducted.There were no non-conformances associated with this complaint.This lot met all release requirements.A review of kit lot p327 shows no trends.Trends were reviewed for complaint category pressure dome leak.No trends were detected for this complaint category.No product or product components have been returned for evaluation.Service verified the pressure dome leak, but the root cause could not be determined.No further action is required at this time; this investigation is now complete.(b)(4).(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 ; 5852335524
• MDR Report Key: 25347898
• Report Number: 3036773437-2026-00050
• Device Sequence Number: 18828534
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P327(17)270501
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 06/01/2026

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: P327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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: 18 YR
• Patient Sex: Male