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 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 m320 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m320 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint categoriy.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 photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).H.M.(b)(6) 2023.

Event Description

The customer contacted mallinckrodt to report that they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed blood around the drive tube latch when they were unloading the kit after the treatment was completed.The customer stated no alarms occurred during the treatment.The customer stated the patient was in stable condition.The customer returned the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit, smart card and photographs were returned for evaluation.A review of the data on the smart card showed that the treatment was completed without the occurrence of any alarms, system errors or warnings.Evaluation of the customer provided photographs verify the drive tube leak as blood residue is visible on the drive tube overmold, where the tri-connector and tubing are bonded together.Examination of the returned kit verified the drive tube leak as a blood leak was identified at the lower end of the drive tube, as seen in the provided photographs.The drive tube was pressure tested to check for leaks and no leaks confirmed during testing of the returned kit.A potential cause of a drive tube leak is due to an insufficient bond between the drive tube and tri-connector joint; however, this could not be verified based on testing of the returned kit as the site of the leak could not be identified.A material trace of the drive tube used to manufacture kit lot m320 did not find any non-conformances.A device history record (dhr) review did not identify any related non-conformances, deviations, or equipment maintenance events.This kit lot passed all lot release testing.The root cause for the reported drive tube 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).H.M.30 jan 2024.

• 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): HARMAC MEDICAL PRODUCTS, INC.; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18185554
• MDR Text Key: 328706313
• Report Number: 3013428851-2023-00078
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)M320(17)250401
• 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: 01/30/2024

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 Catalogue Number: CLXUSA
• Device Lot Number: M320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 66 KG