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

Model Number CELLEX

Device Problems Air Leak (1008); Contamination (1120); Defective Device (2588)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/04/2016

Event Type  malfunction  

Event Description

All noted in collect line during draw phase, approximately 5-10 inch gaps noted.Cleared air, in collect line, therakos contacted.Martin bromley from therakos believed kit is defective and air in line is contaminated.Recommended not to return to patient due to air.Procedure aborted, new kit installed.Cbc ordered by physician due to patient blood loss of 287ml.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• MDR Report Key: 5515885
• MDR Text Key: 40939348
• Report Number: MW5061033
• 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: 03/09/2016

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 Model Number: CELLEX
• Device Lot Number: D312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 54