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 11/18/2021

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a blood leak inside the pto when less than 500 ml of whole blood was processed.The customer decided to proceed with the ecp treatment, and the treatment was completed.The customer reported the patient was in stable condition.The customer will return the kit, smart card, and photographs for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto leak.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 k220 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot k220 shows no trends.Trends were reviewed for complaint category, pto leak.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, smart card and photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.(b)(6) 2021.

Manufacturer Narrative

The complaint kit, smart card and photographs were returned for investigation.Review of the data recorded on the returned smart card showed that the treatment proceeded to the buffy coat collection phase after 1448 ml of whole blood had been processed.Photoactivation was completed and the treatment was successfully completed.The customer provided photographs verify a blood leak from the y-connector in the pump tubing organizer (pto).The leak appears to be coming from the location where the tubing is bonded to the y-connector.Examination of the received kit showed blood residue at the same location of the leak in the photographs.The pto was pressure tested and a leak was verified at the location of the y-connector.The y-connector was sectioned, and inspection found a sink in the bond socket where the yellow stripe tubing is bonded to the socket.A material trace of the y-connector and yellow stripe tubing use to build lot k220 found no non-conformances.A review of all pto leaks documented in mallinckrodt's electronic complaint database did not identify any similar occurrences for kit lot k220.A device history record (dhr) review did not result in any related non-conformances and this kit lot had passed all lot release testing.The root cause of the pto leak was most likely due to a sink in the y-connector bond socket.No further action is required at this time.This investigation is now complete.(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: 13026037
• MDR Text Key: 284302617
• Report Number: 2523595-2021-00106
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: FI
• 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: 03/16/2022

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 Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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