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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/18/2023

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 l004 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l004 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.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 photographs, smart card, and kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).H.M.16 feb 2023.

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 received an alarm #7: blood leak (centrifuge chamber) alarm during treatment after 541ml of whole blood had been processed.The customer observed a blood leak from the drive tube.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.The customer will return the kit, smart card and photographs for investigation.

Manufacturer Narrative

The complaint kit and photographs were returned for evaluation.Review of the provided photographs verify the reported drive tube leak as blood is seen leaking from a groove in the drive tube.The groove in the drive tube is at the location of the upper drive tube bearing.An additional photograph verifies the reported alarm #7: blood leak? (centrifuge chamber) on the cellex display.An alarm #7 occurs when the fluid leak detector in the centrifuge chamber has detected a fluid leak.Evaluation of the returned kit found a circumferential groove on the upper drive tube around the circumference near the upper drive tube bearing stop.The evidence to the drive tube is consistent with a misload of the upper drive tube bearing into the retainer clip causing the drive tube to contact the bearing retainer and leak.The drive tube was pressure tested to check for leaks and a leak was verified at the site of the damage to the drive tube.The root cause for the drive tube leak was most likely caused by not securing the drive tube bearing into the retainer clip during installation of the drive tube 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) 18 apr 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: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 16390523
• MDR Text Key: 309889329
• Report Number: 3013428851-2023-00006
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 04/14/2023

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: 02/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 59 KG