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

Catalog Number CLXECP

Device Problems Break (1069); Fluid/Blood Leak (1250); Protective Measures Problem (3015)

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

Event Date 10/06/2021

Event Type  malfunction  

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 j152 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j152 shows no trends.Trends were reviewed for complaint categories, alarm #47: drive tube alarm and drive tube leak/break.No trends were detected for these complaint categories.Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.Review of the photographs verify the drive tube leak as blood residue is seen at the end of the drive tube overmold, where the tri-connector and tubing are bonded together.A material trace of the drive tube assembly and its components used to build lot j152 identified no related non-conformances.A device history record review for kit lot j152 identified one related unscheduled maintenance event.100% of all kits are subjected to an in-process leak test.Five (5) kits failed the in-process leak test during the manufacture of lot j152.As a result, an unscheduled maintenance event was initiated to investigate the cause of the in-process test failures.A water immersion test was performed on the five failed kits and determined that the leak was occurring at the connection between the drive tube assembly and tri-connector.Review of the related components, solvent bond strength, manufacturing equipment, and assembly process did not identify a cause for the leaks.No additional actions were required as the in-process test screens 100% of all kits for leaks prior to product packaging.No in-process leak test failures occurred during the following manufacturing shift.Subsequent to the packaging and sterilization process, 32 finished product kits are subjected to a simulated use test.Review of the dhr verified that kit lot j152 passed all lot release testing and no leaks were observed.The reported drive tube leak is verified based on the photographs provided; however, a root cause for the leak could not be determined based on the available information.No further action required at this time.This investigation is now complete.(b)(4).

Event 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 at the beginning of the procedure they received an alarm #47: drive tube alarm.The customer inspected the drive tube and observed a blood leak.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 and would begin a new treatment with a new kit.The customer returned photographs for evaluation.

• 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
• MDR Report Key: 12677222
• MDR Text Key: 280453983
• Report Number: 2523595-2021-00090
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/21/2021

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: 12/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: J152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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