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

Catalog Number CLXUSA

Device Problem Component Falling (1105)

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

Event Date 07/02/2014

Event Type  malfunction  

Event Description

After approximately 600ml whole blood processed during the ecp treatment, the interface dropped.Consulted with therakos who was unable to assist in resolving the problem.The treatment was ended.All whole blood was returned to the patient.A new procedural kit was primed and the patient was successfully treated.

Event Description

After approximately 600ml whole blood processed during the ecp treatment the interface dropped.Consulted with therakos who was unable to assist in resolving the problem.The treatment was ended.All whole blood was returned to the patient.A new procedural kit was primed and the patient was successfully treated.

• Brand Name: CELLEX PROCEDURAL KIT
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL, KIT
• Manufacturer (Section D): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• MDR Report Key: 5017656
• MDR Text Key: 23540502
• Report Number: 5017656
• 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
• Report Date: 06/25/2015,07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLXUSA
• Device Lot Number: C322/379
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR