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 03/10/2023

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 approximately 1500mls of whole blood was processed at the time the leak was observed.The customer stated the leak was coming from the photoactivation module during the reinfusion phase of the ecp treatment.The ecp treatment was aborted, and residual blood from the return bag was manually returned to the patient.The customer reported the patient was in stable condition.The customer returned the kit and smart card for evaluation.

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 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 category photoactivation module leak.No trend was 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).N.S.(b)(6) 2023.

Manufacturer Narrative

A batch record review for kit lot l330 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l330 shows no trends.The complaint kit and smart card were returned for evaluation.Review of the smart card data showed that the operator aborted the treatment during the reinfusion phase of the procedure.Examination of the returned kit found a crack in the photoactivation module.The crack runs along the outlet channel and across weld lines indicating the crack was not likely due to an insufficient weld.The photoactivation module was pressure tested and a leak was verified at the site of the crack.A break in the photoactivation module can occur if the photoactivation module is inadvertently damaged during storage, damaged during handling of the kit by the operator, or if there is a weakness in the photoactivation module material.The reported photoactivation module leak was confirmed; however, a definitive root cause for 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).N.S.27-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: 16683644
• MDR Text Key: 313233162
• Report Number: 3013428851-2023-00016
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L330(17)240501
• 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: 04/27/2023

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: 05/01/2024
• Device Catalogue Number: CLXUSA
• Device Lot Number: L330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 54 KG