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 10/20/2023

Event Type  malfunction  

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 the centrifuge bowl broke during the procedure after 1300 mls of whole blood was processed.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 returned the kit for investigation.

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 m322 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot m322 shows no trends.Trends were reviewed for complaint category, centrifuge bowl 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).N.S.16-nov-2023.

Manufacturer Narrative

The complaint kit and smart card were provided by the customer for evaluation.Review of the smart card data showed an alarm #7: blood leak? (centrifuge chamber) alarm occurred after 1425ml of whole blood had been processed.Examination of the received kit found no signs of a leak or any manufacturing issues with the centrifuge bowl.Further examination of the kit found the drive tube was twisted at the location above the upper drive tube bearing stop, and there was a thin wear mark around the circumference of the drive tube.A pressure test was performed to check for leaks and a leak was verified coming from a hole in the drive tube.The upper drive tube bearing stop had delaminated from the drive tube, causing the drive tube to extend during the treatment and impact the centrifuge chamber wall.A material trace of the drive tube assembly and its components used to build lot m322 found no related non-conformances.The device history record (dhr) review did not result in any related non-conformances.This lot passed all lot release testing.The reported centrifuge bowl leak was not verified during testing of the received kit.The root cause of the drive tube leak was most likely due to delamination of the upper drive tube bearing stop.Retraining was completed with manufacturing operators at the manufacturing facility for drive tube delamination failures.No further action is required at this time.The investigation is now complete.(b)(4).(b)(6) 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; buffalo NY 14211
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18148981
• MDR Text Key: 329343989
• Report Number: 3013428851-2023-00076
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)M322(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: 02/09/2024

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: M322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 66 KG