MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PROCEDURAL KIT; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number N/A

Device Problem Improper Flow or Infusion (2954)

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

Event Date 07/06/2014

Event Type  malfunction  

Event Description

Patient was receiving ecp (photopheresis) on the cellex instrument.Five hundred thirty-eight (538) ml whole blood was processed -- the interfaced dropped and from the light red diluted color in the tubing it looked as though recirculation was occurring.Patient was being treated via peripheral iv (piv), single needle mode.Recirculation doesn't occur with pivs.The treatment was ended, all blood processed was returned to the patient.

• Brand Name: CELLEX PROCEDURAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 1001 us route 202; raritan NJ 08869 060
• MDR Report Key: 4272516
• MDR Text Key: 18033203
• Report Number: 4272516
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/29/2014

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: Nurse
• Device Model Number: N/A
• Device Catalogue Number: CLXUSA
• Device Lot Number: C322/365 (KIT)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2014
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 66