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	12/18/2025
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 centrifuge bowl leak/break.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: p311 was conducted.There were no non-conformance's related to the complaint.This lot met all release requirements.A review of kit lot: p311 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.At the time of this report, the analysis of the returned kit is still in process.A final report will be filed when the analysis is complete.(b)(4).(b)(6).On (b)(6) 2026.
Event or Problem Description
The customer contacted therakos to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported the centrifuge bowl broke during the procedure after 1500mls 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 will be returned for evaluation.
Additional Manufacturer Narrative
The complaint kit and smart card were returned for investigation.Evaluation of the received kit verified the reported centrifuge bowl break as the bowl was broken into multiple pieces.Further inspection of the centrifuge bowl showed the bowl base and outer bowl cover had separated.The separation occurred in the outer bowl material and not at the weld that joins the outer bowl to the bowl base, indicating the centrifuge bowl dislodged from the bowl holder and impacted the centrifuge chamber wall.A potential cause for the centrifuge bowl to dislodge out of the bowl holder is due to the bowl not being properly locked into the bowl holder during installation of the kit by the end user.A material trace of the bowl assembly and its components used to build lot p311 found no related 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 centrifuge bowl break is most likely due to the centrifuge bowl not being secured into the bowl holder during installation of the kit by the end user.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: 24100571
• Report Number: 3036773437-2026-00003
• Device Sequence Number: 10312506
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P311(17)270201
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 03/19/2026

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: P311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG