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	12/30/2025
Type of Reportable Event	Malfunction
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 p338 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot p338 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.At the time of this report, the analysis of the returned kit and photographs is still in process.A final report will be filed when the analysis is complete.(b)(4), (b)(6) 2026.
Event or Problem Description
The customer contacted therakos to report they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported a blood leak at the t-connection between the recirculation tubing line and the yellow tubing line.The ecp treatment was aborted and residual blood within the kit was not returned to the patient.The customer reported the patient was in stable condition.The customer provided photographs for evaluation and returned the complaint kit.
Additional Manufacturer Narrative
The complaint kit, smart card and photographs were returned for investigation.Evaluation of the received kit and photographs verified the reported pump tubing organizer (pto) leak.The returned kit was pressure tested to check for leaks and a leak was verified at the t-connector in the pto.The tubing leak indicates that the solvent bond joint was weak.Further inspection of the tubing bond socket verified that solvent was visible 360 degrees around the tubing and was fully inserted into the bond port.A material trace of the spike chamber assembly and tubing used to build lot p338 did not find any non-conformances.A device history record (dhr) review did not result in any related non-conformances.This kit lot passed all lot release testing.The root cause of the tubing leak is most likely due to a weak bond joint between the clear tubing to the t-connector port.It could not be determined why the bond joint was weak based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

• 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: 24198947
• Report Number: 3036773437-2026-00007
• Device Sequence Number: 12139736
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P338(17)270801
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 03/24/2026

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: P338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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 Sex: Unknown