MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

Catalog Number	CELLEX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable due to the medical intervention that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.There has been no known instrument malfunction, and no service has been requested by the customer.No product has been returned.A device service history review has been performed; the instrument has been located at the customer's site since 20/jul/2020, and the instrument has had no documented prior services.Trends were reviewed for complaint category, alarm #10: buffy volume exceeded.No trends were detected for this complaint category.The root cause could not be determined as there was no reported instrument issue, no returned product for investigation, and no instrument service requested by the customer or performed by therakos as a result of this incident.There is no mention of a casual relationship between the patient event(s) and the ecp treatment.This investigation is based on currently available information.No further action is required at this time.This investigation is now complete.Pqc-002210.Jm 30/apr/2026.
Event or Problem Description
The customer contacted therakos to report an alarm #10: buffy volume exceeded was received during an extracorporeal photopheresis (ecp) treatment.The customer reported there were no issues observed during the treatment.The customer reported the treatment was completed, however, an unplanned blood transfusion was adminstered to the patient after treatment.Although requested, no reasoning behind the transfusion has been provided.The patient has been reported to have been stable and in good conditions before the transfusion.No product has been returned for investigation.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Common Device Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS DEVELOPMENT LIMITED; blanchardstown; dublin, D15 A P2D; EI D15 AP2D
• Manufacturer (Section G): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 25046259
• Report Number: 3036773437-2026-00035
• Device Sequence Number: 15932882
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)190104
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown