MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM; CELLEX DEVICE

Model Number CELLEX

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Chest Pain (1776)

Event Date 08/03/2016

Event Type  Injury  

Event Description

Approx 200 ml into the photopheresis procedure, the instrument signaled "air detected" in the return line.The pt was coughing at that time and complaining of chest pressure.The procedure was paused and the lines were clamped.V.S.Were within normal limits.Lung sounds were clear to auscultation.Dry cough persisted but decreased.Md was notified.The return line air was cleared and the procedure re-started.Return air alarm detected again.The procedure was stopped immediately and the md was notified.For safety reasons, the treatment was terminated as ordered.The device was removed from service.Therakos technical support was notified of the event and a request to dispatch a field engineer to evaluate the device was requested.(b)(4).Reason for use: graft versus host disease of the skin.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX DEVICE
• Manufacturer (Section D): THERAKOS, INC.
• MDR Report Key: 6232822
• MDR Text Key: 64262894
• Report Number: MW5067120
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2016

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 Model Number: CELLEX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CELLEX PHOTOPHERESIS KIT: LOT #S313/685, ; EXP: 01/03/2018
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Weight: 68