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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 062 06 14 001
Date submitted: 1/21/2016
Manufacturer:Baxter Healthcare
Device Type:ABACUS Total Parenteral Nutrition (TPN) Calculation Software
Description:Information Systems, Data Management, Provider Order Entry
Medical Device Identifier:ABACUS Total Parenteral Nutrition (TPN) Calculation software Versions 2.0, 2.1, 3.0 and 3.1 (ABACUS). Product code: 8300-0046, 8300-0047
Reason of Field Safety Corrective Action:The manufacturer identified software related issues. Detailed description on the issues is available in the attached letter.

........................

NCMDR update action :

Baxter is sending this communication to announce the release of ABACUS Software version 3.2. Baxter will be implementing ABACUS Software version 3.2 at customer facilities as a correction to the issue communicated in our May 7, 2015 Safety Alert letter, regarding the possibility that the compounder will load the incorrect formula under conditions when two or more different formula files have been created with the same file name.
Remedy Action: Baxter Support Services will be contacting all ABACUS customers by mid of June 2014 to confirm ABACUS is configured appropriately for use of divalent ions in ingredient groups.

You can expect to hear from Baxter Support Services to schedule upgrades and assist you with establishing the proper configuration of ABACUS for your facility.
Athorized Representative/Importer/Distributor:Baxter AG, (011)4343714
Report Source:NCMDR
Source Ref. Number:FA5423877626E
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BAXTER.pdf