MAUDE Adverse Event Report: THERAKOS CELLEX; PHOTOPHERESIS, EXTRACORPORAL

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Unspecified Infection (1930); Respiratory Failure (2484)

Event Date 04/18/2018

Event Type  Injury  

Event Description

This is a pt who has been receiving 1-2x photopheresis for treatment of cgvhd since (b)(6) 2016.Gvhd symptoms primarily significant sclerodermatous changes affecting extremities and trunk and dyspnea.Pt was seen for her routine outpatient ecp on (b)(6) 2018.Prior to treatment, pt had reported uri x1 week being treated with a course of azithromycin and advair.Treatment performed with heparin.The treatment was uneventful.On (b)(6) 2018, pt presented to er for worsening dyspnea.She was ultimately admitted to the micu for respiratory failure.Her workup was significant for findings of new pe at the bifurcation of the left main pulmonary artery.This, in addition to infection and underlying gvhd thought to be contributing to her respiratory distress.Pt is currently stable on bipap, receiving antibiotics and heparin transitioning to lovenox.

• Brand Name: THERAKOS CELLEX
• Type of Device: PHOTOPHERESIS, EXTRACORPORAL
• MDR Report Key: 7568958
• MDR Text Key: 110222346
• Report Number: MW5077642
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 64