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

Catalog Number CLXECP

Device Problems Break (1069); Disconnection (1171); Leak/Splash (1354)

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

Event Date 06/12/2021

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 h150 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h150 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.Photographs were provided by the customer for evaluation.The complaint kit was not returned.Review of the provided photographs verify the tri-connector has detached from the drive tube.In addition, the photographs verify the reported alarm #7: blood leak (centrifuge chamber) alarm occurred on the cellex monitor display.An alarm #7 occurs when fluid is detected within the centrifuge chamber.A material trace of the tri-connector used to build lot h150 did not find any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.Manufacturing operators are to visually inspect the joint between the tri-connector and drive tube to ensure there is no gap present, and the bond between the tri-connector and drive tube is sufficient.The root cause of the drive tube leak is most likely due to a manufacturing operator error during the tube bonding operation.Retraining has been completed with all bonding operators.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2021.

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 during the collect phase of the procedure they received an alarm #7: blood leak? (centrifuge chamber) alarm.The customer checked the kit and noticed the drive tube line had disconnected.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer returned photographs 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): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; shelbourne building; 53 frontage rd suite 300; hampton, NJ 08827
• MDR Report Key: 12145835
• MDR Text Key: 266376515
• Report Number: 2523595-2021-00061
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/09/2021

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 Expiration Date: 09/01/2021
• Device Catalogue Number: CLXECP
• Device Lot Number: H150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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 Weight: 42