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 09/19/2023

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 l156 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot l156 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 and kit are still in process.A final report will be filed when the analysis is complete.(b)(4).N.S.(b)(6) 2023.

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 blood inside the centrifuge chamber after 1439ml 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 will return the kit and photographs for investigation.

Manufacturer Narrative

The complaint kit, photographs and smart card data were returned for evaluation.Review of the smart card data confirmed the occurrence of an alarm #7: blood leak? (centrifuge chamber) alarm after approximately 1439 ml of whole blood had been processed.The customer provided photographs verify the drive tube leak as blood splatter is visible on the centrifuge chamber walls.Examination of the returned kit found damage to the drive tube at the location of the lower drive tube bearing stop.The damage to the drive tube is consistent with a drive tube that is not rotating freely and contacts the drive tube retainer, resulting in a leak.The drive tube was pressure tested to check for leaks and a leak was verified at the location of the damage to the drive tube.A material trace of the drive tube assembly and its components used to build lot l156 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 cause of the damage to the drive tube was most likely due to the drive tube contacting the drive tube retainer clip.The root cause for the 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).N.S.16-jan-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; cruiserath road; castlerea roscommon, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 17957113
• MDR Text Key: 325938384
• Report Number: 3013428851-2023-00060
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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: L156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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: Male
• Patient Weight: 81 KG