MAUDE Adverse Event Report: MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED CELLEX PHOTOPHERESIS SYSTEM; CELLEX PHOTOPHERESIS SYSTEM, PRODUCT CODE: LNR

Catalog Number CLXUSA

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

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

Event Date 07/14/2021

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 j372 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j372 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.Photographs and the smart card data were provided by the customer for evaluation.The complaint kit was not returned for investigation.A review of the smart card data showed a blood leak (centrifuge) alarm occurred after 246ml 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.Further review of the photographs show the base of the centrifuge bowl is still contained within the bowl holder, indicating the outer bowl had separated from the bowl base.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.A material trace of the bowl assembly and its components used to build lot j372 found no related non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.This kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely due to a separation of the outer bowl and bowl base; however, the cause of the separation could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

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 during the purging air phase of the procedure the centrifuge bowl broke.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 and smart card data for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM, PRODUCT CODE: LNR
• 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: 12318163
• MDR Text Key: 268034901
• Report Number: 2523595-2021-00068
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J372(17)220901
• 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: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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
• Patient Age: 67 YR
• Patient Weight: 69