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	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted therakos to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported an alarm #7: blood leak? (centrifuge chamber) occurred and a blood leak was observed from the drive tube.The customer reported the blood leak appeared to be coming from the top drive tube portion near the bearing.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The customer will return the kit and smart card for evaluation.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube 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: p307 was conducted.There were no non-conformance's related to the complaint.This lot met all release requirements.A review of kit lot: p307 shows no trends.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak? (cent chamber) alarm.No trends were detected for these complaint categories.At the time of this report, the analysis of the returned kit and smart card is still in process.A final report will be filed when the analysis is complete.(b)(4).(b)(6).On (b)(6) 2026.
Additional Manufacturer Narrative
An investigation has been performed based on the customer complaint description and the returned kit and smart card.The received kit was intact.Visual inspection found blood on the exterior of the drive tube around the upper bearing.The drive tube bearing stop has been worn away and the bearing now appears to be lodged over what remains of the stop.The bearing could not be spun by hand.No other damage was observed to the rest of the drive tube.A pressure test was performed to determine the location of the leak.The lines leading to the drive tube were cut to separate it from the rest of the kit.A leak test confirmed a leak below where the bearing was placed.A review of smart card data confirmed the drive tube was neither damaged nor leaking as received.During lot release testing (lrt), 32 kits from lot p307 were tested with no issues reported.A material trace of the drive tube assembly and its components used to build lot p307 found no related non-conformances.A device history record (dhr) review did not result in any related nonconformances.This lot passed all lot release testing.The root cause of the damaged drive tube could not be determined.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: 24496284
• Report Number: 3036773437-2026-00013
• Device Sequence Number: 18801226
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)P307(17)270201
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 05/05/2026

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: P307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 43 YR
• Patient Sex: Male