MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PROCEDURAL KIT

Catalog Number CLXUSA

Device Problem Positioning Problem (3009)

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

Event Date 03/25/2014

Event Type  malfunction  

Event Description

Upon installation of the photopheresis procedural kit, the nurse noted the centrifuge bowl tubing to be slighting more than usual after being secured by the two brackets of the centrifuge bowl arm.Therakos inc.Was called to inquire about it.By therakos recommendation the kit installation was not completed.The kit was removed and saved for the manufacturer's analysis.

• Brand Name: THERAKOS CELLEX PROCEDURAL KIT
• Type of Device: THERAKOS CELLEX PROCEDURAL KIT
• Manufacturer (Section D): THERAKOS INC.
• MDR Report Key: 3815407
• MDR Text Key: 17931210
• Report Number: MW5036114
• 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: Other
• Type of Report: Initial

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: 01/01/2016
• Device Catalogue Number: CLXUSA
• Device Lot Number: C303
• Other Device ID Number: CLXUSA
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• Patient Sequence Number: 1