MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM

Catalog Number	CLXSP-I
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted mallinckrodt to report they experienced a pressure dome leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a leak next to the system pressure dome after 60ml of whole blood had been processed.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 returned photographs for investigation.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome leak.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 n178 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot n178 shows no trends.Trends were reviewed for complaint category, pressure dome leak.No trends were detected for this complaint category.Photographs were returned for evaluation.The complaint kit and smart card were not returned for evaluation.Review of the customer provided photographs confirms the report of a pressure dome leak as blood is present at the base of the system pressure dome and on the pump deck.A material trace of the pressure dome housing assembly and its components used to build lot n178 did not find any non-conformances.The device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.The reported pressure dome leak is verified based on the photographs provided; however, the root cause for the pressure dome leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4), (b)(6) 2025.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Common Device Name: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• 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: 22667678
• Report Number: 3013428851-2025-00100
• Device Sequence Number: 12645697
• Product Code: LNR
• UDI-Device Identifier: 00705030000005
• UDI-Public: (01)00705030000005(10)N178(17)261101
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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: N178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2024
• 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 Sex: Unknown