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

Catalog Number CLXUSA

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 04/16/2021

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 j366 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j366 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The complaint kit was not returned.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.Further review of the photographs show the drive tube component of the kit intact.The drive tube is no longer secured into its retainer clips.A material trace of the bowl assembly and its components used to build lot j366 found no related non-conformances.A device history record review did not identify any related non-conformances, deviations or equipment maintenance events.This kit lot had passed all lot release testing.The centrifuge bowl break is verified based on the provided photographs; however, a 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).(b)(6) 2021.

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 approximately 223 ml of whole blood had been processed when the centrifuge bowl broke.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 and started a new ecp treatment with a new kit on a different instrument.The customer returned photographs for investigation.

• 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: 11787803
• MDR Text Key: 268476786
• Report Number: 2523595-2021-00047
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J366(17)220801
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• 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