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	01/31/2025
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 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 n125 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot n125 shows no trends.Trends were reviewed for complaint category, pressure dome leak.No trends were detected for this complaint category.At the time of this report, the analysis of the returned photographs is still in process.A final report will be filed when the analysis is complete.(b)(4).
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 that the return pressure dome leaked during treatment after 100ml 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 evaluation.
Additional Manufacturer Narrative
Photographs were returned for evaluation.The complaint kit and smart card were not returned for evaluation.Examination of the customer provided photograph confirmed the leak from the pressure dome.A material trace of the pressure dome housing assembly and its components used to build lot n125 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) 13 mar 2025.(b)(4).

• 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: 21395858
• Report Number: 3013428851-2025-00017
• Device Sequence Number: 15752866
• Product Code: LNR
• UDI-Device Identifier: 00705030000005
• UDI-Public: (01)00705030000005(10)N125(17)260201
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Expiration Date: 02/01/2026
• Device Catalogue Number: CLXSP-I
• Device Lot Number: N125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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