MAUDE Adverse Event Report: THERAKOS CELLEX; CELLEX PHOTOPHERESIS KIT

Model Number CELLEX

Device Problems Break (1069); Loose or Intermittent Connection (1371); Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

During the set-up of the cellex photopheresis kit, it was noted the drive tube was not tightly fitting the centrifuge bowl brackets.The tubing was sliding up and down.When the drive tube is not tightly secured in the brackets and as the procedure starts, the centrifugal force used for the procedure may cause the drive tube to break inside the centrifuge compartment, therefore resulting in patient's blood loss.The patient was not connected to the device.The defect was noted during the installation of the kit.

• Brand Name: CELLEX
• Type of Device: CELLEX PHOTOPHERESIS KIT
• Manufacturer (Section D): THERAKOS; bridgewater 08807
• MDR Report Key: 4278561
• MDR Text Key: 5031431
• Report Number: MW5039241
• 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: 11/18/2014

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 Expiration Date: 08/01/2016
• Device Model Number: CELLEX
• Device Lot Number: C339
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1