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 11/14/2022

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #17: return pressure alarm and noticed a blood leak coming from the pto at the location of the blood filter.The customer reported approximately 900ml of whole blood was processed at the time the leak was observed.The ecp treatment was aborted and residual blood within the kit was not returned to the patient.The customer reported the patient was in stable condition.The customer returned photographs and the smart card for evaluation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto 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 l323 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l323 shows no trends.Trends were reviewed for complaint categories alarm #17: return pressure and pto 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 and smart card are still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Manufacturer Narrative

The customer provided photographs and the smart card data for evaluation.The complaint kit was not returned.Review of the smart card data verified the occurrence of multiple alarm #17: return pressure alarms for pressure below the lower limit.The alarms occurred after approximately 844ml of whole blood had been processed, and the treatment was not completed.The customer provided photographs verify a blood leak inside the pump tubing organizer (pto).The leak appears to be coming from the blood filter and air bubbles are seen in the filter.The cause of the reported alarm #17: return pressure alarm was most likely due to the blood leak within the kit.The root cause of the pto 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.22-feb-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: 15946263
• MDR Text Key: 307951975
• Report Number: 3013428851-2022-00086
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L323(17)240401
• 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: 02/22/2023

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: 04/01/2024
• Device Catalogue Number: CLXUSA
• Device Lot Number: L323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 71 KG