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 03/21/2024

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 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 kit is still in process.A final report will be filed when the analysis is complete.(b)(4).H.M.(b)(6) 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 that during the treatment, the centrifuge bowl came out of the bowl holder and cracked the drive tube.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 customer will return the kit 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; i.d.a. business park; castlerea roscommon, ; EI
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 19022599
• MDR Text Key: 339150010
• Report Number: 3013428851-2024-00027
• 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
• Report Date: 04/02/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/02/2024
• 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