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

Catalog Number CLXUSA

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/14/2021

Event Type  malfunction  

Event Description

The customer contacted mallinckrodt to report they experienced clots observed in the return line with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they observed a blood clot in the return line during the procedure.The customer reported the ecp treatment was completed, and blood was returned to the patient.The customer reported the patient was in stable condition.The customer discarded the kit and returned a video for evaluation.

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction clot observed in the return line.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A kit lot number was not provided; therefore, a batch record review could not be performed.Trends were reviewed for complaint category, clot observed.No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned video is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Manufacturer Narrative

Two videos were provided by the customer for evaluation.The complaint kit and smart card were not returned.The customer provided video verifies blood solids in the return line of the kit.The fluid seen moving through the return line is a pale-yellow color and not completely red.The second video shows the return pump head rotating with blood in the tubing line.There are some blood solids visible in the tubing line; however, the blood clots could not be verified based on the videos provided.Section 2-9 of the cellex operators manual (1460415 rev 5.0) on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgement to establish the optimal heparin dosage for each patient." the root cause for the clotting observed could not be determined based on the available information.No manufacturing related defects were identified during this investigation.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6).(b)(6) 2022.

• 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: 12924269
• MDR Text Key: 288831802
• Report Number: 2523595-2021-00100
• Device Sequence Number: 1
• Product Code: LNR
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/29/2021
• Supplement Dates FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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