MAUDE Adverse Event Report: MACK MOLDING COMPANY CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM

Model Number CELLEXUSA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816)

Event Date 01/09/2023

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the patient's hospitalization and also due to the medical intervention of the heparin 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 instrument issue was alleged by the customer.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 12-jun-2017.As part of the review, it was determined that the instrument's last service prior to the event was on 25-may-2022 (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 and pulmonary embolism could not be determined as there was no reported instrument issue, 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.Thromboembolic events are a labelled side effect of the therakos® cellex® photophoresis system.In the cellex operator manual, section 2-9 anticoagulation, the caution section states "special attention to adequate anticoagulation is advised when treating patients with gvhd, a condition associated with an increased risk of thromboembolic events.Thromboembolic events (including pulmonary embolism and deep vein thrombosis) have been reported with the use of the therakos® cellex® photophoresis system in the treatment of gvhd an indication which is not approved in the us." trends were reviewed for complaint categories, dyspnea and pulmonary embolism.No trends were detected for these complaint categories.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 terms: dyspnea and pulmonary embolism.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced dyspnea and a pulmonary embolism following their ecp treatment procedure.The customer stated that on (b)(6) 2023 a graft versus host disease (gvhd) patient presented to their ecp unit complaining of shortness of breath.The customer reported that the patient did not receive their scheduled ecp treatment procedure that day.The customer stated that the patient was admitted to the hospital that day and a ct scan confirmed a bilateral pulmonary embolism.The customer reported that the patient's last ecp treatment procedure prior to their pulmonary embolism diagnosis was on (b)(6) 2022 and this treatment was successfully completed.The customer stated that the patient had received three ecp treatment procedures at their facility with a frequency of every two weeks.The customer reported that the anticoagulant heparin was used at a ratio of 10:1 during the patient's ecp treatment procedures.The customer stated that the patient did not have a history of elevated platelets or a clotting disorder.The customer reported that the patient was prescribed a heparin protocol while in the hospital for their pulmonary embolism.The customer stated that the patient was discharged from the hospital the following day, (b)(6) 2023, on anticoagulants.The customer reported that their medical director re-approved the patient for ecp treatments on (b)(6) 2023 with the patient on anticoagulant medication.The customer stated that the patient is stable and is currently receiving ecp treatments.The customer reported that the patient's physician believed that the patient's pulmonary embolism and increased thrombosis risk was related to their ecp treatments.No product was returned for investigation.

• Brand Name: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX EXTRACORPOREAL PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): MACK MOLDING COMPANY; 608 warm brook rd; arlington VT 05250
• 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: 16572585
• MDR Text Key: 311580104
• Report Number: 3013428851-2023-00012
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)170227
• 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
• Report Date: 03/20/2023

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
• Device Operator: Health Professional
• Device Model Number: CELLEXUSA
• Device Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2023
• Initial Date FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 28 YR
• Patient Sex: Male