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	04/02/2026
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 p312 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot p312 shows no trends.Trends were reviewed for the complaint centrifuge bowl leak/break, and no trends were detected for this complaint category.At the time of this report, the complaint investigation is still in process.A final report will be filed when the investigation is complete.(b)(4).29/apr/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 that the break occurred with 100 ml of whole blood having been processed; the bowl shattered and separated at the connection site to the drive tube and the top of the bowl.The centrifuge leak detector strip was also damaged.The customer reported no difficulty installing the bowl in the bowl holder, citing the bowl clicking into place.A very small piece of metal hanging by the upper drive tube bearing has also been reported.The treatment was aborted, and the patient has been reported to have been stable.The customer has provided photographs and has returned the kit for evaluation.There was no report of patient harm associated with this event.

• 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; suite 302; bridgewater, NJ 08807 ; 5852335524
• MDR Report Key: 25033639
• Report Number: 3036773437-2026-00036
• Device Sequence Number: 8920061
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P312(17)270201
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 06/12/2026

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: P312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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: 87 YR
• Patient Sex: Male