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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/22/2024

Event Type  malfunction  

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 that during the treatment, the centrifuge bowl came out of the bowl holder and the drive tube was severely twisted.The ecp treatment was aborted, and 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 provided photographs for evaluation.

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 m128 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot m128 shows no trends.Trends were reviewed for complaint category, drive tube leak/break.No trends were detected for this complaint category.At the time of this report, the analysis of the returned photographs is still in process.A final report will be filed when the analysis is complete.(b)(4) (b)(6) on (b)(6) 2024.

Manufacturer Narrative

Photographs were returned for evaluation.The complaint kit and smart card were not returned for evaluation.Examination of the customer provided photographs confirmed the centrifuge bowl dislodged from the bowl holder and the drive tube was severely twisted.Further evaluation of the customer photograph confirmed a small blood leak was present on the drive tube.A known cause for the centrifuge bowl to dislodge out of the bowl holder is due to the centrifuge bowl not properly locked into the bowl holder during installation of the kit by the end user.A material trace of the bowl assembly and its components used to build lot m128 found no related non-conformances.The 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 root cause of the drive tube leak is most likely due to the centrifuge bowl not being secured into the bowl holder during installation of the kit by the end user.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6).31 may 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; i.d.a. business park; castlerea roscommon, ; IT
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 19052533
• MDR Text Key: 339556114
• Report Number: 3013428851-2024-00030
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: CLXECP
• Device Lot Number: M128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2023
• 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