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

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 12/07/2020

Event Type  malfunction  

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 j340 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j340 shows no trends.Trends were reviewed for complaint categories, drive tube 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 kit and photographs 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 that they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that approximately 628 mls of whole blood was processed when they received an alarm #7: blood leak (centrifuge chamber) alarm and a leak on the drive tube was observed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer stated that the patient was stable.The customer returned the kit and photographs for investigation.

Manufacturer Narrative

Corrected data: d3: manufacturer address, g1: contact office site address the complaint kit and photographs were returned for evaluation.The provided photographs verify the drive tube leak as blood splatter is seen on the centrifuge chamber walls.The centrifuge bowl and drive tube components appear to be intact and still secured in the centrifuge arm.Examination of the returned kit found dried blood on the drive tube between the upper and lower drive tube bearing stops.The centrifuge bowl and drive tube were pressure tested to check for leaks and a leak was verified at a small pin hole near the location of the upper drive tube bearing stop.Further inspection of the drive tube found no signs of short shot, sink, or any other molding issues.A material trace of the drive tube used to manufacture lot j340 showed no 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 cause of the reported alarm #7: blood leak? (centrifuge chamber) alarm was due to the drive tube leak.The root cause of the damage to the drive tube that resulted in the leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4) p.T.16-feb-2021.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; blanchardstown, dublin NJ D15 T X2V; EI D15 TX2V
• MDR Report Key: 11122692
• MDR Text Key: 241663999
• Report Number: 2523595-2021-00001
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J340(17)220501
• Combination Product (y/n): Y
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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 Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 88