MAUDE Adverse Event Report: THERAKOS DEVELOPMENT LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number	CLXSP-I
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
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 of the clot observed in the return line.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 n266 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot n266 shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure and clot observed.No trends were detected for these complaint categories.The customer provided photographs for evaluation.The kit was not returned.Review of the photographs confirmed the presence of blood clots in the kit.The blood clots are seen in centrifuge bowl and return lines.Section 5-26 of the cellex operators' manual (b)(4) for use with software 5.7 on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." the root cause of the alarm #17: return pressure alarm was due to the clots in the kit.The root cause for the clots in the kit could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4) n.S.(b)(6) 2025.
Event or Problem Description
The customer contacted therakos to report blood clotting in the return line with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported an alarm #17: return pressure alarm occurred, and they observed blood clots in the return line after 949mls of whole blood was processed.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 kit return was requested; however, the customer will not return the kit.The customer returned photographs for investigation.
Additional Manufacturer Narrative
The smart card data and photographs were returned for evaluation.The complaint kit was not returned for evaluation.A review of the data on the returned smart card confirmed the occurrence of multiple alarm #17: return pressure warnings during a blood prime treatment that was not completed.A visual inspection of the customer provided photographs confirmed the presence of clots in multiple parts of the kit.Section 5-26 of the cellex operators manual (1470619_rev03) for use with software 5.7 on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." the most likely root cause for the alarm #17: return pressure is due to the clots in the kit.The root cause for the clots in the kit could not be determine based on the available information.No further action is required at this time.(b)(6).

• 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; i.d.a. business park; castlerea roscommon, ; EI
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 23622409
• Report Number: 3036773437-2025-00018
• Device Sequence Number: 18386847
• Product Code: LNR
• UDI-Device Identifier: 00705030000005
• UDI-Public: (01)00705030000005(10)N266(17)261101
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: CLXSP-I
• Device Lot Number: N266
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 27 KG