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 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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, centrifuge bowl leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.A visual inspection of the customer-supplied photographs showed that the drive tube and centrifuge bowl are damaged.The centrifuge bowl had dislodged out of the bowl holder and impacted the inside of the centrifuge chamber during the treatment.A known cause for the centrifuge bowl to dislodge out of the bowl holder is due to the bowl not being properly locked into the bowl holder during installation 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 most likely root cause of the centrifuge bowl break is 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.The investigation is now complete.(b)(4).(b)(4) 15-apr-2024.

Event Description

The customer contacted mallinckrodt to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a bowl break at the beginning of the treatment.The ecp treatment was aborted and residual blood within the kit was not returned to the patient.The patient was reported to be in stable condition.The kit return was requested; however, the customer discarded the kit.

• 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, ; EI
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 19110673
• MDR Text Key: 340812198
• Report Number: 3013428851-2024-00029
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/15/2024

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: 03/28/2024
• Initial Date FDA Received: 04/15/2024
• 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
• Patient Sex: Female
• Patient Weight: 40 KG