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

Catalog Number CLXECP

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 12/01/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #8: blood leak? (photoactivation chamber) alarm.The customer observed a blood leak in the photoactivation chamber and noticed a break in the photoactivation plate.The customer reported approximately 1312 of whole blood had been processed.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.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 photoactivation module 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 k104 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot k104 shows no trends.Trends were reviewed for complaint categories, alarm #8: blood leak? (photoactivation chamber) and photoactivation module leak.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 photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).H.M.15 dec 2022.

Manufacturer Narrative

Photographs were returned by the customer for evaluation.The complaint kit was not returned.Review of the provided photographs verify the reported photoactivation module leak as blood is seen leaking from the photoactivation module and inside the photoactivation chamber.The smart card was not returned, therefore the alarm #8: blood leak? (photoactivation chamber) could not be verified.An alarm #8 occurs when the fluid leak detector in the photoactivation chamber has detected a fluid leak.A material trace of the photoactivation plate halves used in lot k104 found no related non-conformances.A device history record (dhr) review did not result in any related nonconformances.This kit lot passed all lot release testing.The cause of the reported alarm #8 was most likely due to the leak in the photoactivation chamber.The root cause of the photoactivation module 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).

• 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: 15992281
• MDR Text Key: 308269140
• Report Number: 3013428851-2022-00091
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: CLXECP
• Device Lot Number: K104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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 Sex: Female