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

Catalog Number CLXECP

Device Problems Unintended Ejection (1234); Protective Measures Problem (3015)

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

Event Date 02/16/2022

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 at the beginning of the procedure they received an alarm #52: collect line air detected alarm and observed a leak from the collect pressure dome.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 and successfully completed a new treatment with a new kit.The customer returned photographs 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 j122 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j122 shows no trends.Trends were reviewed for complaint categories, alarm #52: collect line air detected and pressure dome leak.No trends were detected for these complaint categories.The customer provided photographs for investigation.The complaint kit and smart card were not returned.The customer provided photographs verify the reported pressure dome leak during the ecp treatment.The photographs show the diaphragm had detached from the pressure dome housing.There is no visible damage to the pressure dome housing or diaphragm.An additional photograph verifies the reported alarm #52: collect line air detected alarm on the cellex monitor display.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.A material trace of the pressure dome housing assembly and its components used to build lot j122 did not find any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The cause of the reported alarm #52: collect line air detected is most likely due to the pressure dome leak.The root cause of the pressure dome leak is most likely due to the pressure dome not being secured to the pressure sensor during installation of the kit by the end user.No further action is required at this time.This investigation is now complete.(b)(4).

• 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: megan vernak ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 13894536
• MDR Text Key: 294655099
• Report Number: 3013428851-2022-00024
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/24/2022

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: 06/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: J122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 86 KG