MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number	CLXCC-I
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted therakos to report they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") occurring during the blood prime phases of an extracorporeal photopheresis (ecp) treatment.The customer reported that the leak appeared to be coming from the return reservoir and that the patient had not yet been connected.The customer also reported that alarm #57: return pump (#3) error also occurred.The kit has been discarded, but the customer provided photographs for evaluation.No patient harm has been reported.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto 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 n277 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot n277 shows no trends.Trends were reviewed for complaint categories, pto leak and alarm # 57: return pump (#3) error.No trends were detected for these complaint categories.At the time of this report, the complaint investigation is still in process.A final report will be filed when the investigation is complete.Pqc-002153 jm 05/may/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; i.d.a. business park; castlerea roscommon, ; EI
• Manufacturer Contact: brian stimson ; 1170 us highway 22; suite 302; bridgewater, NJ 08807 ; 5852335524
• MDR Report Key: 25086205
• Report Number: 3036773437-2026-00049
• Device Sequence Number: 10409688
• Product Code: LNR
• UDI-Device Identifier: 00705030000029
• UDI-Public: (01)00705030000029(10)N277(17)261201
• Combination Product (Y/N): Y
• Initial Reporter Country: EI
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: CLXCC-I
• Device Lot Number: N277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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