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

Catalog Number CLXUSA

Device Problem Leak/Splash (1354)

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

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction bag 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 l321 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot l321 shows no trends.Trends were reviewed for complaint category, bag leak.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The complaint kit was not returned.Review of the provided photographs verify the reported bag leak.The needle-free port had disconnected from the treatment bag port.A material trace of the needle-free port and its components used to build lot l321 found no related non-conformances.A device history record (dhr) review did not identify any related non-conformances, deviations or equipment maintenance events.This lot passed all lot release testing.The needle-free port detaching from the treatment bag port indicates the solvent bond joint was insufficient.The root cause of the bag leak is most likely due to manufacturing operator error during the tube bonding process.Retraining has been completed for the affected operators.No further action is required at this time.This investigation is now complete.Comp# (b)(4).N.S.On (b)(6) 2022.

Event Description

The customer contacted mallinckrodt to report they experienced a bag leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported approximately 1494ml of whole blood was processed at the time the leak was observed.The customer reported the leak occurred at the injection port of the treatment bag, after the buffy coat collection phase of the treatment was completed.The customer completed the ecp treatment and blood was returned to the patient.The customer reported the patient was in stable condition.The customer returned photographs for investigation.

• 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: 15896693
• MDR Text Key: 307580258
• Report Number: 3013428851-2022-00082
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)L321(17)240301
• 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
• Report Date: 12/01/2022

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: 03/01/2024
• Device Catalogue Number: CLXUSA
• Device Lot Number: L321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: 67 KG