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 11/30/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a pressure dome leak with their cellex photopheresis kit during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a leak at the pressure sensor after the treatment was completed.The customer was unloading the kit at the time the leak was observed, and the patient had already been disconnected.The customer returned the kit and smart card for investigation.

Manufacturer Narrative

The system was used for treatment.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 l004 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l004 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 analysis of the returned kit and smart card is still in progress.A supplemental report will be filed when the analysis is complete (b)(4).(b)(6) 2022.

Manufacturer Narrative

The complaint kit was returned for investigation.The smart card was not returned.A visual inspection of the kit found no obvious manufacturing issues.Inspection of the collect, return, and system pressure domes did not identify a blood leak.The diaphragms on the collect, return, and system pressure domes were properly seated and exhibited no damage.In addition, the pressure domes were not damaged.The pressure domes were installed onto a pressure sensor to assess fit, all pressure domes latched into the circumferential groove around the sensor as expected.The three pressure domes were pressure tested to check for leaks and no leaks were identified.The customer complaint was not verified.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now complete.Comp-037692 h.M.22 mar 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 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 16040628
• MDR Text Key: 307810406
• Report Number: 3013428851-2022-00089
• 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: 03/22/2023

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: 02/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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