X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
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