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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Abbott Cardiovascular and Neuromodulation
CentriMag Acute Circulatory Support System Motor
Compatible with CentriMag Pump and PediVas Pump
Medical Device Identifier:
Reason of Field Safety Corrective Action:
Abbott is advising you that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support.
-Patient Management Recommendations Below are recommendations for clinicians managing patients using the CentriMag System within a hospital or clinic:
-A full backup system must be in the immediate vicinity of every patient supported by the CentriMag System.
-Exchange the pump to the backup system as described in the CentriMag System Operating Manual and in Appendix 2. Improperly exchanging the motor to a backup console only could cause damage.
-Inspection of the CentriMag Motor, including the cable, for damage should be conducted prior to use. Do not use if damaged. If the cable is damaged and not visible as part of the inspection, the console will alarm during the procedure.
-Please contact your local Abbott MCS Clinical Specialist for additional information about this program. Future System Enhancements Changes are being qualified that are intended to make the motor cable more resistant to damage and will be implemented after the design is fully developed and regulatory approval is received. We will promptly inform you when these designs become available.
Arabian Trade House Est.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.