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

Catalog Number CLXECP

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 10/11/2022

Event Type  malfunction  

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 category, photoactivation module leak.No trends were detected for this complaint category.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 photographs and smart card data is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).H.M.08 nov 2022.

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 they observed a leak coming from the photoactivation plate after the treatment was successfully completed.The customer reported the patient was in stable condition.The customer discarded the kit and returned photographs and the smart card data for investigation.

Manufacturer Narrative

The customer returned photographs and the smart card data for evaluation.The complaint kit was not returned.A review of the data on the smart card verified the treatment was successfully completed without the occurrence of any alarms, system errors or warnings.The customer provided two photographs for evaluation.The first photograph shows the treatment bag filled with air and a small amount of blood at the bottom.The second photograph shows the inlet and outlet ports of the photoactivation module.Further evaluation of the photograph shows small cracks on the photoactivation module where the inlet and outlet ports are located.During incoming inspection photoactivation plates are sampled and inspected for any obvious damage or defects.No issues were found during incoming inspection for the lots used to manufacture kit lot l204.The reported photoactivation module leak could not be verified based on the photographs provided.A material trace of the photoactivation plates used to build lot l204 did not find any non-conformances.A device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.The customer complaint was not verified based on the available information.No further action is required at this time.This investigation is now complete.Comp-(b)(4).H.M.22 dec 2022.

Manufacturer Narrative

The complaint kit was returned for investigation.Examination of the received kit found cracks on the photoactivation module where the inlet and outlet ports are located.The photoactivation module was pressure tested and a leak was verified at the site of the cracks.A known cause for cracks in the photoactivation module is due to excessive solvent used during manufacturing.The solvent can cause damage to the photoactivation module if too much solvent is used and left to set within the plate.The excess solvent is from the bonds that join the tubing and port on the photoactivation module together, causing the plate to crack from the inside out.A material trace of the photoactivation plates used to build lot l204 did not find any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.During incoming inspection photoactivation plates are sampled and inspected for any obvious damage or defects.No issues were found during incoming inspection for the lots used to manufacture kit lot l204.The root cause of the photoactivation module leak is most likely due to excessive solvent during the tube bonding process by the manufacturing operator.Retraining has been completed for the relevant operators to reinforce proper tube bonding instructions.No further action is required at this time.This investigation is now complete.Comp-(b)(4).H.M.17 jul 2023.

• 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): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 15751402
• MDR Text Key: 303299161
• Report Number: 3013428851-2022-00079
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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,Followup
• Report Date: 07/17/2023

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: 10/11/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 12/05/2022; 06/22/2023
• Supplement Dates FDA Received: 12/22/2022; 07/17/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Male