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

Model Number CLXUSA

Device Problems Malposition of Device (2616); Difficult to Open or Close (2921)

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

Event Date 11/08/2019

Event Type  malfunction  

Event Description

The tubing in kit was not in the correct place and therefore not closing with the pump.This allowed additional normal saline to infuse to the patient.Patient treatment completed successfully.The patient received more fluid than normal, but tolerated the fluid increase.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 1425 us route 206; bedminster NJ 07921
• MDR Report Key: 9353625
• MDR Text Key: 167345973
• Report Number: 9353625
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: H338
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2019
• Date Report to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA