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

Catalog Number CLXECP

Device Problem Break (1069)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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: l120 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot: l120 shows no trends.Trends were reviewed for complaint category centrifuge bowl leak/break.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 kit and photograph are still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).Ns 22-dec-2022.

Event Description

The customer contacted mallinckrodt to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported the centrifuge bowl broke at the beginning of the ecp treatment.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The customer returned the kit and a photograph for evaluation.

Manufacturer Narrative

The complaint kit, smart card and photographs were provided by the customer for evaluation.Review of the smart card data verified the prime was completed and blood collection began in double needle mode.The treatment proceeded until an alarm #7: blood leak (centrifuge chamber) alarm occurred after 100 ml of whole blood had been processed.Review of the provided photographs verify the centrifuge bowl broke as blood splatter is visible on the centrifuge chamber walls, and pieces of the centrifuge bowl are located at the bottom of the centrifuge chamber.Examination of the received kit found the centrifuge bowl broken into several pieces.Further examination of the centrifuge bowl found the centrifuge bowl base was in one piece, and a large portion of the outer bowl was still connected to the drive tube.There is a piece of the outer centrifuge bowl still attached to the bowl base, indicating that the break occurred in the outer bowl material and not at the weld between the outer bowl and bowl cover.It appears the centrifuge bowl had dislodged from the bowl holder during the treatment and impacted the centrifuge chamber wall.A known cause for a centrifuge bowl to dislodge from the bowl holder is when it isn't secured in the bowl holder during installation of the kit by the end user.A material trace of the bowl assembly and its components used to build lot l120 found no related non-conformances.A device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.The root cause of the centrifuge bowl break was most likely due to the centrifuge bowl not being secured into the bowl holder during installation of the kit by the end user; however, a definitive root cause could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).N.S.(b)(6)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: megan vernak ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 16040110
• MDR Text Key: 308388845
• Report Number: 3013428851-2022-00090
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLXECP
• Device Lot Number: L120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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 Sex: Female
• Patient Weight: 73 KG