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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 071 07 11 000
Date submitted: 7/18/2011
Manufacturer:Gambro
Device Type:Dialysis system, Gambro Prismaflex system
Description:Dialysis system
Medical Device Identifier:Software 5.00 or 6.00 with "Citrate - Calcium via prismaflexe Syringe Pump" anticoagulation method unlocked.
Reason of Field Safety Corrective Action:The Prismaflex system offers the "Citrate - Calcium via Prismaflex Syringe Pump" anticoagulation method, which includes the provision of a Calcium solution through the Prismaflex syringe pump. Gambro has become aware of a deficiency in the control of the Prismaflex syringe pump, which can potentially lead to a rapid and uncontrolled infusion of the remaining volume of calcium solution (max 50 ml) into the patient. This can potentially result in severe patient injury or death.
Remedy Action:As a corrective action, the new software version 6.10 will be implemented in all affected Prismaflex systems. Customers are urgently advised not to use the "Citrate - Calcium via Prismaflex Syringe Pump" anticoagulation method until the corrective actions have been implemented. In the meantime, customers are asked to switch to any of the other anticoagulation methods that are offered by the Prismaflex system, including systemic anticoagulation based on the "Standard - Syringe" anticoagulation method, or the "Citrate - Calcium via External Infusion Pump" anticoagulation method. Customers are asked to refer to the Prismaflex Operators Manual for further information on these options, or to contact their local Gambro representative. The new software version 6.10 will be implemented in all affected Prismaflex systems not later than end of August 2011.
Athorized Representative/Importer/Distributor:Arabian Medical Marketing Co. (AMCO), Riyadh, (01) 4887122
Report Source:NCAR
Source Ref. Number:SE-2011-07-15-027
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments