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

Catalog Number CLXECP

Device Problem Crack (1135)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #52: collect line air detected alarm after 192 ml of whole blood had been processed.The customer inspected the needle-free injection port on the collect line, and noticed it was cracked. the customer aborted the ecp treatment and returned residual blood within the kit to the patient.There was no report of patient harm associated with this event.The customer discarded the kit and returned photographs and the smart card for evaluation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 l211 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l211 shows no trends.Trends were reviewed for complaint categories, alarm #52: collect line air detected and tubing leak.No trends were detected for these complaint categories.Photographs and the smart card data was provided by the customer for evaluation.The complaint kit was not returned.A review of the data on the smart card verified the occurrence of multiple alarm #52: collect line air detected alarms during a treatment that was not completed.A review of the provided photographs show the needle-free port on the collect line is cracked.Further examination of the photographs verify the tubing leak as blood is seen leaking out of the needle-free port on the collect line.A material trace of the needle free "y" ports used to build lot l211 did not find any non-conformances.A device history record did not result in any related non-conformances.This lot passed all lot release testing.The cause of the alarm #52: collect line air detected is most likely due to the crack in the needle-free port on the collect line.The root cause for the damage to the needle-free port could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Comp:(b)(4).13 mar 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: 16534005
• MDR Text Key: 311597365
• Report Number: 3013428851-2023-00014
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: NO
• 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
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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