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

Catalog Number CLXECP

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

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

Event Date 11/10/2021

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 k111 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k111 shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break and alarm #7: blood leak? (centrifuge chamber).No trends were detected for these complaint categories.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 smart card and photograph is still in progress.A supplemental report will be filed when the analysis is 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 the centrifuge bowl broke after approximately 220 ml of whole blood had been processed.The customer reported they received an alarm #7: blood leak? (centrifuge chamber) following the bowl break.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 smart card and photographs for investigation.

Manufacturer Narrative

Photographs and the smart card were returned for evaluation.The complaint kit was not returned.A review of the data recorded on the smart card confirmed the occurrence of an alarm #7: blood leak (centrifuge chamber) after 228ml of whole blood had been processed.The customer provided photographs verify the centrifuge bowl broke as blood splatter is visible on the centrifuge chamber walls and the centrifuge bowl is in several pieces at the bottom of the centrifuge chamber.The base of the outer bowl appears to be intact and is contained within the bowl holder.A large piece of the outer bowl is still connected to the bowl base.A material trace of the bowl assembly and its components used to manufacture lot k111 found no non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The cause of the reported alarm #7: blood leak (centrifuge chamber) was most likely due to the centrifuge bowl break.The root cause of the centrifuge bowl break 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)(4) (b)(6) 2022.

• 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: 12961457
• MDR Text Key: 285823356
• Report Number: 2523595-2021-00103
• 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: 02/03/2022

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 Expiration Date: 02/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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: Male