MalfunctionLNR
THERAKOS CELEX PHOTOPHERESIS SYSTEM
Received Jul 25, 2019 · Event occurred Jun 18, 2019
Report MW5088393 · MDR key 8831144
Device
Generic name
System, Photopheresis, Extracoporation
Manufacturer
Therakos / Mallinckrodt Hospital Products Inc.Product problems
- Output Problem
Patient
52 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE THERAKOS CELEX PHOTOPHERESIS SYSTEM FAILED TO COLLECT A BUFFY COAT TO BE TREATED. THE MFR WAS CONTACTED TO TROUBLESHOOT BUT NO SOLUTION WAS FOUND. THE PT'S BLOOD WAS RETURNED WITHOUT LOSS OR ADVERSE EVENT. THE SMART CART FROM THE PROCEDURE WAS RETURNED TO MALLINCKRODT FOR ANALYSIS BUT NO ROOT CAUSE WAS DETERMINED BY THEM. FDA SAFETY REPORT ID# (B)(4).