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 Codes	Anemia (1706); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Tachycardia (2095); Malaise (2359); Low Oxygen Saturation (2477)
Date of Event	03/03/2026
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 (b)(6) 2023, and no prior service events have been documented.No trends for malaiset, tachycardia, hypoxia / hypoxemia, high blood pressure/ hypertension, low hematocrit, or low hemoglobin have been observed.The root cause for the patient's adverse events 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.In addition, the patient's hematocrit was lower than recommended when starting the treatment.The healthcare professional stated they believe that the patient's underlying condition(s) could have caused or contributed to the medical intervention performed.This investigation is based on currently available information.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 patient feeling "unwell" during an extracorporeal photopheresis (ecp) treatment.Hemoglobin had dropped to 6.9, so a blood transfusion was administered.The treatment had begun with hematocrit at 22%.At the start of ecp treatment, systolic blood pressure was 140mmhg, but dropped to 90mmhg during treatment.Spo2 was also unstable, ranging from around 90 to 97%, so a small amount of oxygen was administered via the nasal passage.The whole blood processing volume was changed to 1250ml, and treatment continued, after which it was terminated.The customer has stated that they believe the patient's underlying condition could have caused or contributed to the interventions performed, however, it is unknown if the ecp treatment necessitated the oxygen delivery.The patient remains hospitalized.It is unknown if the patient will be continuing ecp treatment.No product was 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 VA 05250
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 24735514
• Report Number: 3036773437-2026-00028
• Device Sequence Number: 18747369
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)221107
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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; Hospitalization
• Patient Sex: Female
• Patient Weight: 50 KG