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 09/21/2023

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a pressure dome leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a leak after the system pressure dome came off at the beginning of the treatment.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, the smart card and kit for investigation.

Manufacturer Narrative

The system was used for treatmnet.This case is reportable as a mdr due to the reportable malfunction pressure dome 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 l146 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l146 shows no trends.Trends were reviewed for complaint category, pressure dome 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 complaint kit and smart card have not yet been received.A supplemental report will be filed when the analysis is complete.(b)(4).H.M.02 oct 2023.

Manufacturer Narrative

A photograph was returned by the customer for investigation.The complaint kit was not returned.Review of the customer provided photograph verifies the reported pressure dome leak during the ecp treatment.Examination of the photograph shows a blood leak at the location of the centrifuge system pressure sensor.A material trace of the pressure dome housing assembly and its components used to build lot l146 did not find any non-conformances.A device history record (dhr) review did not result in any related non-conformances.This kit lot passed all lot release testing.The reported pressure dome leak is verified based on the photographs provided; however, the root cause for the pressure dome 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).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): HARMAC MEDICAL PRODUCTS; i.d.a. business park; cruiserath road; castlerea roscommon, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 17852270
• MDR Text Key: 324701604
• Report Number: 3013428851-2023-00063
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CLXECP
• Device Lot Number: L146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2022
• 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