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

Catalog Number CLXECP

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 07/01/2021

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 j146 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j146 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.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).P.T.(b)(6) 2021.

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") after an extracorporeal photopheresis (ecp) treatment was completed.The customer reported the ecp treatment was successfully completed and blood was returned to the patient.The customer reported when unloading the kit they observed a blood leak on the drive tube component of the kit.The customer reported the patient was in stable condition.The customer returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit with smart card, and photographs were returned for investigation.Review of the smart card data verified the treatment was successfully completed and blood was returned to the patient.The provided photographs verify the drive tube leak as residual blood is seen on the lower drive tube overmold, and in the drive tube clamp.Examination of the received kit found dried blood on the lower drive tube overmold.There was no obvious signs of damage to the drive tube or its components.The drive tube was pressure tested under both positive and negative pressure and no leaks were identified.A material trace of the drive tube assembly and its components used to build lot j146 found no related 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 drive tube leak was verified based on the photographs provided; however, testing of the complaint kit did not identify any leaks.The root cause of the drive tube 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.(b)(6) 2021.

• 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
• MDR Report Key: 12255087
• MDR Text Key: 266375803
• Report Number: 2523595-2021-00063
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: J146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 64