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 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review for kit lot l227 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l227 shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.At the time of this report, the analysis of the returned photograph is still in process.A final report will be filed when the analysis is complete.(b)(4).

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 leak in the pump tubing organizer (pto) during the photoactivation phase of the treatment.The customer reported approximately 1553 ml of whole blood was processed.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 returned a photograph for investigation.

Manufacturer Narrative

A photograph was provided by the customer for evaluation.The complaint kit and smart card were not returned.Examination of the provided photograph verifies a blood leak occurred in the pump tubing organizer (pto).Further evaluation shows the blood leak appears to be coming from the port where the yellow stripe tubing is bonded to the y-connector.A device history record (dhr) review for kit lot l227 did not result in any related non-conformances.This kit lot passed all lot release testing.A material trace of the y-connector and tubing used to build lot l227 was performed and did not find any non-conformances.The tubing leak from the bond port inside the pto indicates the solvent bond joint was insufficient.The root cause for the pto leak was most likely due to manufacturing operator error during the tube bonding operation.Retraining has been completed with applicable bonding operators who perform this operation.No further action is required at this time.This investigation is now complete.(b)(4) h.M.(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, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: mark wendelken ; 440 route 22 eas; suite 302; bridgewater, NJ 08807
• MDR Report Key: 16683200
• MDR Text Key: 313516404
• Report Number: 3013428851-2023-00015
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 05/05/2023

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: 06/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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: Female