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

Catalog Number CLXECP

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 l112 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l112 shows no trends.Trends were reviewed for complaint category, tubing 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 photographs and kit are still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).(b)(6) 2023.

Event Description

The customer contacted mallinckrodt to report they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported the leak was observed during the buffy coat collection phase of the procedure.The leak appeared to be coming from the location of the recirculation pump tubing.The customer aborted the ecp treatment and manually returned the blood from the return bag to the patient.The customer reported the patient was in stable condition and began a new ecp treatment with a new kit.The customer will return the complaint kit and photographs for investigation.

Manufacturer Narrative

The complaint kit and photographs were returned for evaluation.Review of the customer provided photographs verify the reported tubing leak as the recirculation pump tubing is seen detached from the tubing port.The photographs verify the customer report of plasma leaking on the pump deck.Examination of the received kit verified the recirculation pump tubing was no longer bonded to the t-connector port.Further inspection of the kit found a lack of solvent on the tubing that is bonded to the t-connector port.The tubing detaching from the bond port indicates the solvent bond joint was insufficient.A material trace of the tubing and its components used to build lot l112 found one related non-conformance.The related non-conformance was associated with black stripe tubing lot # 1010393 which involved a leak identified at the same location during lot release testing for a different kit lot.A device history record review for kit lot l112 did not identify any related non-conformances and this kit lot had passed all lot release testing.The root cause of the tubing leak is most likely due to manufacturing operator error during the tube bonding operation.Retraining was completed with all bonding operators at the manufacturing facility.No further action is required at this time.This investigation is now complete.(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, blanchardstown D15 T X2V; EI D15 TX2V
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 16477534
• MDR Text Key: 310801753
• Report Number: 3013428851-2023-00008
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 06/06/2023

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: 04/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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 Sex: Male