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

Catalog Number	CELLEX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a pediatric extracorporeal photopheresis (ecp) patient experienced dyspnea following their ecp treatment procedure.The customer reported that the patient was being treated with ecp for acute graft versus host disease.The customer stated that the patient was an inpatient and unwell due to their underlying condition.The customer reported that the patient's ecp treatment procedure was performed in single needle mode due to venous access issues.The customer stated that the patient's ecp treatment procedure was successfully completed.However, the customer reported that the patient was "slightly" over their 15% safe extracorporeal blood volume (ecv) by 2mls.The customer stated that during the patient's ecp treatment procedure 762mls of whole blood was processed and the patient had an end fluid balance of 310mls.The customer reported that the patient was stable throughout their ecp treatment procedure.The customer stated that overnight, several hours post the patient's ecp treatment procedure, the patient complained of dyspnea.The customer reported that the patient's oxygen saturation was satisfactory.The customer stated that the patient was given the diuretic, furosemide (lasix), for their dyspnea.The customer reported that they plan to start fluid restriction with this patient and to also insert an apheresis line to resolve the patient's venous access issue so the patient can carry on with their ecp treatments.The customer stated that the reason for the patient's dyspnea was multicausal as the patient was an acutely ill inpatient due to their underlying condition, on multiple iv therapies for their underlying condition, and their ecp treatment procedure was "slightly" over their 15% safe extracorporeal blood volume (ecv) by 2mls.No product was returned for investigation.
Additional Manufacturer Narrative
The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the furosemide that was provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no service was requested by the customer for this adverse event.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since 15-mar-2017.As part of the review, it was determined that the instrument's last service prior to the event was on 28-nov-2023 (annual preventive maintenance).During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.The root cause for the patient's dyspnea could not be determined as there was no reported instrument malfunction, no product was returned for investigation, and no instrument service was requested by the customer or performed by therakos as a result of this incident.The customer stated that the reason for the patient's dyspnea was multicausal as the patient was an acutely ill inpatient due to their underlying condition, on multiple iv therapies for their underlying condition, and their ecp treatment procedure was "slightly" over their 15% safe extracorporeal blood volume (ecv) by 2mls.Trends were reviewed for complaint category, dyspnea.No trends were detected for this complaint category.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event term: dyspnea.(b)(4) 29-jan-2024.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Common Device Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer (Section G): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• Manufacturer Contact: mark wendelken ; 440 route 22 east; suite 302; bridgewater, NJ 08807
• MDR Report Key: 18603558
• Report Number: 3013428851-2024-00013
• Device Sequence Number: 18396332
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170105
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: P860003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female