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

Model Number CELLEX

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Date 07/29/2016

Event Type  malfunction  

Event Description

During air purge phase of ecp treatment a system pressure alarm occurred.Much air noted to be in centrifuge bowl.Resumed treatment and a second system pressure alarm occurred.At this point a blood leak was noted on the pump deck of the machine.Patient's central line was immediately clamped off and patient disconnected from the tubing.Not able to return the estimated 75cc blood that had been collected due to probable contamination.Patient stable.Md notified.Further treatment held for the day.Biomed inspected machine and kit.Kit to be returned to therakos to further investigate.

• Brand Name: CELLEX PHOTOPHERESIS KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; west chester PA 19380
• MDR Report Key: 6088887
• MDR Text Key: 59479446
• Report Number: 6088887
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2016

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: CELLEX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR