MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number	CLXUSA
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
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 malfunctions, alarm #7: blood leak (centrifuge chamber) and drive tube lreak/break.Since these reportable malfunctions are associated only with the kit, this mdr will be only against the kit.A batch record review for kit lot p328 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot p328 shows no trends.Trends were reviewed for complaint categories alarm #7: blood leak (centrifuge chamber) and drive tube leak/break.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.(b)(4).(b)(6) 2026.
Event or Problem Description
The customer contacted therakos to report an alarm #7: blood leak (centrifuge chamber) and a drive tube leak/break, both of which 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, and residual blood was not returned to the patient.After opening the centrifuge chamber door, the customer noticed the top of the drive tube appeared twisted.The customer mentioned no difficulties installing the kit and reported a fine mist of blood in a circular motion on the wall and blood on the chamber ceiling.No holes were observed.The customer has returned photographs for evaluation.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: brian stimson ; 1170 us highway 22; suite 302; bridgewater, NJ 08807 ; 5852335524
• MDR Report Key: 25153477
• Report Number: 3036773437-2026-00039
• Device Sequence Number: 18830711
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P328(17)270501
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: P328
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2025
• 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: 57 YR
• Patient Sex: Male