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 04/08/2024

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 m357 was conducted.There were no non-conformances related to this complaint.This lot met all release requirements.A review of kit lot m357 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.The complaint kit and smart card were not returned.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.A material trace of the drive tube used to manufacture lot m357 found one non-conformance.The non-conformance was associated with kit lot m357 which involved a leak identified at the drive tube and tri-connector joint during lot release testing.The 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.Review of mallinckrodt's electronic complaint database did not identify any similar occurrences for kit lot m357.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 photographs provided.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.29 apr 2024.

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed leak at the base of the drive tube after the treatment was aborted.No residual blood within the kit was returned to the patient.The customer reported the patient was in stable condition.The kit return was requested; however, the customer discarded the kit.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): 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: 19201409
• MDR Text Key: 341637676
• Report Number: 3013428851-2024-00036
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)M357(17)250801
• 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: 04/29/2024

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: M357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• 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: 34 YR
• Patient Sex: Male