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

Catalog Number CLXECP

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 07/15/2022

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 they received an alarm #8: blood leak? (photoactivation chamber) alarm.The customer noticed the photoactivation plate broke during the photoactivation phase of the procedure after 1540 ml of whole blood have been processed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer returned photographs 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 k254 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k254 shows no trends.Trends were reviewed for complaint categories, photoactivation module leak, alarm #8: blood leak (photoactivation chamber), and alarm #7: blood leak (centrifuge chamber).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 photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Manufacturer Narrative

A photograph was provided by the customer for evaluation.The complaint kit and smart card were not returned.Review of the photograph verifies the photoactivation module leak as blood is seen leaking through a crack in the photoactivation module.A material trace of the illumination plates used to build lot k254 did not find any non-conformances.A device history record (dhr) review did not result in any related non-conformances.This lot was passed all lot release testing.All photoactivation plates are inspected prior to packaging; therefore, it is unlikely the crack to the photoactivation module was present at the time of manufacture.The cause of the 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 was due to the cracks in the plate; however, the cause of the crack 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.15 sep 2022.

• 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: megan vernak ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 15169513
• MDR Text Key: 305266964
• Report Number: 3013428851-2022-00057
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 09/15/2022

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: 11/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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