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 12/15/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they received an alarm #7: blood leak? (centrifuge chamber) alarm with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they inspected the centrifuge chamber and a small amount of blood was visible.The customer could not determine the source of the leak.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition and would begin a new ecp treatment with a new kit.The customer did not return product for investigation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction alarm #7: blood leak? (centrifuge chamber).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: l206 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot: l206 shows no trends.Trends were reviewed for complaint category, alarm #7: blood leak? (centrifuge chamber).No trends were detected for this complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6).21 dec 2022.

Manufacturer Narrative

Photographs were returned by the customer for evaluation.The complaint kit and smart card were not returned.Review of the provided photographs verify the reported blood leak as blood is visible inside the centrifuge chamber door, and in the centrifuge bowl holder.The origin of the leak could not be determined based on the photographs provided.The complaint kit is not visible in the photographs.The reported alarm #7: blood leak? (centrifuge chamber) could not be verified as the smart card was not returned.A known cause for alarm #7 as per the cellex operators manual is the centrifuge fluid leak detector has detected a potential fluid leak.A material trace of the centrifuge bowl used to build lot l206 did not find any non-conformances.A device history record (dhr) review did not result in any related non conformances.This lot passed all lot release testing.The root cause for the reported alarm #7: blood leak? (centrifuge chamber) was most likely due to the leak in the centrifuge chamber.The cause of the 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).(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: megan vernak ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 16029000
• MDR Text Key: 308563327
• Report Number: 3013428851-2022-00094
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 02/16/2023

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: 01/01/2024
• Device Catalogue Number: CLXECP
• Device Lot Number: L206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1