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

Catalog Number CLXUSA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/10/2023

Event Type  malfunction  

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 l348 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l348 shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak and alarm #18: system pressure.No trends were detected for these complaint categories.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 is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).Hm: (b)(6) 2023.

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 at the system pressure dome after 400 ml of whole blood had been processed.The customer reported that an alarm #18: system pressure alarm occurred and then the blood leak was observed.The ecp treatment was aborted and no residual blood within the kit was retuned to the patient.The patient was reported to be in stable condition.The customer returned the kit for investigation.

Manufacturer Narrative

The kit was returned for evaluation.The smart card was not returned for evaluation, therefore the reported alarm #18: system pressure could not be confirmed.The kit was returned intact and dried blood was observed on the body and membrane of the system pressure dome, confirming the reported complaint.Examination of the returned kit found the diaphragm was partially unseated from the body of the system pressure dome.The pressure dome was inspected and no obvious manufacturing issues were found.The diaphragm was put back into place on the body of the pressure dome and was pressure tested to check for leaks.Pressure testing of the pressure dome did not result in any leaks.If a pressure dome is not properly attached to its pressure sensor because one of its latches isn't secured in the circumferential groove around the sensor, the diaphragm of the pressure dome will have room to move and can become unseated when pressure is increased.All cellex kits are leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the pressure dome leaked at the time of manufacture.The cause of the reported leak was most likely due to the diaphragm becoming unseated from the body of the pressure dome.The root cause of the pressure dome leak was most likely due to the pressure dome not being secured to the pressure sensor during installation of the pressure dome by the end user.No further action is required at this time.This investigation is now complete.(b)(4).H.M.25 apr 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: 16477500
• MDR Text Key: 310957381
• Report Number: 3013428851-2023-00010
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L348(17)240801
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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 Catalogue Number: CLXUSA
• Device Lot Number: L348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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 Age: 13 YR
• Patient Sex: Male