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

Catalog Number CLXUSA

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Twisted/Bent (2981)

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

Event Date 12/14/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they were performing a blood prime and received an alarm #7: blood leak (centrifuge chamber).The customer inspected the centrifuge chamber and observed a leak coming from the drive tube.The customer stated the drive tube was twisted at the location of the drive tube bearing retainer clip.The patient was not connected at the time the leak was observed.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer returned a photograph for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube 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: l330 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot: l330 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.A photograph was provided by the customer for evaluation.The complaint kit and smart card were not returned.Review of the customer supplied photograph verifies the drive tube break as the drive tube is seen twisted at the location of the upper drive tube bearing stop.The provided photograph shows the upper drive tube bearing is not secured into the drive tube retainer clip.A known cause of a broken drive tube is when the drive tube is not rotating freely.A material trace of the drive tube assembly and its components used to build lot: l330 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 drive tube break is most likely due to the upper drive tube bearing not being properly secured into its bearing retainer by the end user.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now complete.(b)(4).(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: 16141442
• MDR Text Key: 308838501
• Report Number: 3013428851-2023-00001
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L330(17)240501
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLXUSA
• Device Lot Number: L330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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