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	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported the drive tube broke during treatment after 1425ml 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 the kit for investigation.
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 n123 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot n123 shows no trends.Trends were reviewed for complaint category, drive tube 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).H.M.10 feb 2025.
Additional Manufacturer Narrative
The kit and smart card were returned for investigation.A review of the smart card data confirmed the reported alarm #7: blood leak? (cent chamber) occurred after 1547ml of whole blood had been processed.The kit was returned intact and a visual inspection of the drive tube did not find any holes, cuts or blemishes.A pressure test was performed on the drive tube and no leaks were observed.A pressure test was also performed on the plasma cell outlet and whole blood inlet lines and a leak was confirmed at the weld joining the base of the bowl to the outer bowl.A material trace of the bowl assembly and its components used to build lot n123 found no-related non-conformances.The device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.Examination of the returned kit confirmed the blood leak reported by the customer; however, the leak was discovered coming from a crack on the outer bowl instead of the drive tube.The root cause for the crack in the outer bowl could not be determined based on the available information.H.M.02 apr 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: 21348618
• Report Number: 3013428851-2025-00011
• Device Sequence Number: 7835153
• Product Code: LNR
• UDI-Device Identifier: 00705030000005
• UDI-Public: (01)00705030000005(10)N123(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): 04/02/2025

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: N123
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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