InjuryKDL
SERVATOR H
Received May 10, 2019
Report MW5086577 · MDR key 8604843
Device
Generic name
Set, Perfusion, Kidney, Disposable
Manufacturer
S.a.l.f. Laboratorio FramacologicoProduct problems
- Product Quality Problem
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
PRODUCT CLAIMS TO HAVE SHELL LIFE OF 18 MONTHS. FDA APPROVAL FOR 12 MONTHS. PRODUCT IS VERY YELLOW IN COLOR. TEMPERATURE GUIDELINES ARE NOT THE SAME AS PREDICATE. FDA SAFETY REPORT ID# (B)(4).