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

Device Problem Failure to Prime (1492)

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

Event Date 11/18/2016

Event Type  malfunction  

Event Description

Cellex system would not prime.Therakos support called.The device could not be fixed with troubleshooting over the telephone.Therakos sent technician to repair equipment.Therakos technician repaired the device.

• Brand Name: CELLEX SYSTEM
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 10 north hight street; suite 300; west chester PA 19380
• MDR Report Key: 6185001
• MDR Text Key: 62718843
• Report Number: 6185001
• 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: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2016
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR