X
Your changes have been successfully saved
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
N
ational
C
enter for
M
edical
D
evices
R
eporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home
Published FSNs/Recalls
About NCMDR
Contact Us
FAQ
Login
NCAR Recall
Back
Reference Number:
mdprc 008 05 14 000
Date submitted:
5/5/2014
Manufacturer:
Fresenius Kabi Ltd
Device Type:
INJECTOMAT AGILIA Range (Std, MC & TIVA), VOLUMAT AGILIA Range (Std & MC)
Description:
Infusion pump / Syringe pump
Medical Device Identifier:
INJECTOMAT AGILIA Range (Std, MC & TIVA), VOLUMAT AGILIA Range (Std & MC)
Reason of Field Safety Corrective Action:
Fresenius Vial France, had 3 incidents reports concerning 3 different issues :
A. Concerning Injectomat and Volumat pumps:
A.1. “Watchdog” error message during communication with PDMS (reporting of patients data)
A.2. Technical error when a programming is done with a medication with a concentration in mg/mL
B. Concerning Injectomat pumps: technical error n° 23
Remedy Action:
Fresenius decided to upgrade software versions
Athorized Representative/Importer/Distributor:
Gulf Medical Co., Jeddah, (012) 6512828
Report Source:
NCAR
Source Ref. Number:
FR-2014-04-18-032
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
No Attachments
View History
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.