MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT; CELLEX KIT

Model Number CELLEX PHOTOPHERESIS KIT

Device Problems Break (1069); Failure to Prime (1492); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2015

Event Type  Injury  

Event Description

Recurrent alarms during the installation of the cellex photopheresis kit.During the prime cycle the alarm 4 kept coming on.Two photopheresis kits had to wasted.The manufacturer was contacted and the 2 kits were returned to the manufacturer for investigation.Report requested.This event did not reach the pt.

• Brand Name: CELLEX PHOTOPHERESIS PROCEDURAL KIT
• Type of Device: CELLEX KIT
• Manufacturer (Section D): THERAKOS; bridgewater NJ 08807
• MDR Report Key: 5207808
• MDR Text Key: 30712504
• Report Number: MW5057723
• Device Sequence Number: 2
• 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: 11/02/2015
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 06/01/2017
• Device Model Number: CELLEX PHOTOPHERESIS KIT
• Device Lot Number: D335
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention