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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported an alarm #8: blood leak (photoactivation chamber) occurred and observed a leak in the photoactivation module.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The patient was reported to be in stable condition.The customer will return photos, kit and smart card for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module 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 l204 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l204 shows no trends.Trends were reviewed for complaint categories, alarm #8: blood leak? (photoact chamber) and photoactivation module leak.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photos, smart card and kit is still in process.A final report will be filed when the analysis is complete.(b)(4).H.M.20 nov 2023.

Manufacturer Narrative

The complaint kit and photographs were returned for evaluation.The smart card was not returned; therefore, the reported alarm #8: blood leak? (photoactivation chamber) could not be verified.Review of the customer provided photographs verify the reported photoactivation module leak as a crack is visible in the center of the module.Examination of the received kit verified a large crack on the surface of the photoactivation module.The photoactivation module was pressure tested to check for leaks and a leak was verified coming from the crack in the module.A material trace of the illumination plates used to build lot l204 did not find any non-conformances.The device history record (dhr) review did not result in any related non-conformances.This kit lot passed all lot release testing.There were no illumination plates rejected for cracks during manufacturing of this kit lot.The cause of the reported alarm #8: blood leak? (photoactivation chamber) was most likely due to the leak in the photoactivation chamber.The root cause of the photoactivation module 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).H.M.19 feb 2024.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: 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: 18172787
• MDR Text Key: 328638224
• Report Number: 3013428851-2023-00077
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: SW
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1