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

Device Problems Misconnection (1399); Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/15/2015

Event Type  Injury  

Event Description

Patient with a central tri lumen pheresis catheter.The access and return lines were connected to the photopheresis access and return ports and the procedure was started.Within minutes of initiation of the procedure, the blood in the centrifuge and the return bag was noted by rn to be visually abnormal.Also, therakos cellex ecp machine alarmed.The procedure was immediately paused.Bts physician was paged and arrived at the bedside.It was concluded that the blood was clotted and the procedure was aborted.Upon further inspection of the photopheresis machine and applied kit, including the lines and the normal saline and acda (anticoagulant) fluids, it was discovered that the anticoagulant line from the machine was connected to the normal saline bag, and the normal saline line from the machine, was connected to the anticoagulant bag.With all other apheresis kits (different apheresis machines), green lines designate the normal saline connection, orange lines designate connection to anticoagulant fluid.Ecp photopheresis kit designates a clear line to indicate connection to normal saline and a line with a green stripe to indicate use for the anticoagulant line.Therefore, it is counter intuitive to apheresis practice to connect a green line to an anticoagulant solution.The concern of misconnecting normal saline and anticoagulant lines has been brought to the attention of the manufacturer,therakos, on multiple occasions.They are aware of this concern, and the potential for connection errors.To prevent this type of error from occurring again with an ecp procedure, the nurse director applied a green tag to the anticoagulant hook on the machine, and the staff rn applied green tape stripe above the connection hook on the machine.These 2 visual aids will further remind staff to connect green striped tubing from the kit to the anticoagulant bag.All staff were informed of this added safety feature the following day.

• Brand Name: THERAKOS CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS; 10 north high street; suite 300; west chester PA 19380
• MDR Report Key: 5466045
• MDR Text Key: 39212576
• Report Number: 5466045
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 27 YR