MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM LIGHT ASSEMBLY; CELLEX PHOTOACTIVATION LIGHT

Model Number CLXLGT

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2016

Event Type  Injury  

Event Description

While priming the photopheresis device, lamp failure alarm was detected.All attempts to clear the alarm failed.The lamp had approx over 40 hrs remaining.New light assembly was installed and the intended procedure was completed without further alarms.Reason for use: chronic graft versus host disease.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM LIGHT ASSEMBLY
• Type of Device: CELLEX PHOTOACTIVATION LIGHT
• Manufacturer (Section D): THERAKOS, INC.
• MDR Report Key: 6232821
• MDR Text Key: 64262911
• Report Number: MW5067119
• 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: 08/02/2016

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: CLXLGT
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 61