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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 074 06 17 000
Date submitted: 6/22/2017
Manufacturer:BD Biosciences
Device Type:Model 8015 Alaris System PC Units
Description:Infusion Pumps
Medical Device Identifier:Model 8015 Alaris System PC Units
Reason of Field Safety Corrective Action:System Error May Occur under Certain Circumstances, Potentially Resulting in Interruption of Infusion
Remedy Action:BD states that your Alaris system will not need to be remediated. Refer to the user manual addendum for instructions on how to avoid the occurrence of the system error. If the system error occurs, the Alaris System modules will continue as programmed. Do not interrupt critical infusions if infusion parameters do not need to be edited. If it is safe to do so, manually stop the infusion to reprogram and restart the pump following the instructions in the user manual addendum to avoid this error. Power down the PC unit by pressing the SYSTEM ON key. Restart the device by pressing the SYSTEM ON key. Restart previous infusions and/or monitoring settings. If the system error returns, power down the PC unit and replace it immediately. Return the PC unit to your biomedical engineering department for troubleshooting and data log retrieval. (See Attached FSN)
Athorized Representative/Importer/Distributor:Becton Dickinson B.V.
Report Source:NCMDR
Source Ref. Number:362850F11F1BE
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: BD Biosciences.pdf