MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Catalog Number CELLEX

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

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

Event Date 01/08/2020

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 the medical intervention of the treatment/medical management that were provided to the patient.Since this event is associated with the treatment, this mdr will be against the instrument.A device service history review could not be performed as an instrument serial number was not provided.Trends were reviewed for complaint categories shortness of breath 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 shortness of breath and a pulmonary embolism following a treatment procedure.The customer stated that the patient had received their ecp treatments from (b)(6) 2019 through (b)(6) 2020 for chronic graft versus host disease (gvhd).The customer reported that heparin at an 8:1 ratio was used as the anticoagulant for the patient's ecp treatment procedures.The customer stated that the patient came to the bone and marrow transplant clinic on (b)(6) 2020, and the patient reported that for the last several weeks he had shortness of breath when lying flat.The customer reported that the patient's shortness of breath had progressed to intermittent periods of shortness of breath with difficulty in taking a deep breath.The customer reported that a pulmonary computed tomography scan was performed which indicated an acute right upper lobe pulmonary embolism.The customer stated that the patient was admitted to the hospital from (b)(6) 2020 for treatment/medical management.The customer reported that the patient was now in stable condition.No product was returned for investigation.

Event Description

The customer reported on (b)(6) 2020 that the patient had been placed on xarelto as treatment for their pulmonary embolism.The customer stated that the patient continued with their extracorporeal photopheresis (ecp) treatments after their pulmonary embolism diagnosis on (b)(6) 2020.The customer reported that the patient underwent six additional ecp treatment procedures with the patient's last ecp treatment on (b)(6) 2020.

Manufacturer Narrative

This supplemental follow-up report was written in order to capture the additional information that was provided by the customer on (b)(6) 2020.A device service history review was performed.The instrument has been located at the customer's site since (b)(6)2013.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6)2019.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.(b)(4).(b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• MDR Report Key: 9821714
• MDR Text Key: 196419492
• Report Number: 2523595-2020-00049
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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 Catalogue Number: CELLEX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 97