MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number	CLXSP-I
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
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 drive tube leak/break.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 p166 was conducted.There were no non-conformances associated with this complaint.This lot met all release requirements.A review of kit lot p166 shows no trends.Trends were reviewed for complaint category drive tube leak/break.No trends were detected for this complaint category.No product, product component(s), or photographs have been returned for evaluation.An investigation has been performed based on the customer complaint description and the therakos service report associated with this incident.Service did replace modification kit 18, which includes drive tube bearing retainers.The root cause, however, could not be determined.No further action is required at this time; this investigation is now complete.(b)(4), (b)(6) 2026.
Event or Problem Description
The customer contacted therakos to report a drive tube leak/break that occurred with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.Approximately 1425 ml of whole blood had been processed.The customer denies any difficulty with the centrifuge installation.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.

• 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: 25470843
• Report Number: 3036773437-2026-00052
• Device Sequence Number: 10465638
• Product Code: LNR
• UDI-Device Identifier: 30705030000006
• UDI-Public: (01)30705030000006(10)P166(17)270701
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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 Expiration Date: 06/01/2026
• Device Catalogue Number: CLXSP-I
• Device Lot Number: P166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• 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