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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 056 12 18 000
Date submitted:	12/16/2018

Manufacturer:	Terumo BCT Inc.
Device Type:	Trima Accel® Automated Blood Collection System
Description:	Apheresis Units, Blood Donor
Medical Device Identifier:	Trima Accel® Automated Blood Collection System
Reason of Field Safety Corrective Action:	This letter provides information about the new IV pole collar accessory for the Trima Accel system. New Trima Accel systems will be shipped with an IV pole collar (See figure 1 in the attached FSN). This feature has been added to avoid a pinch point between the IV pole cross bar and the machine while lowering the IV pole. On new machines, the service technicians will attach the IV pole collar to the IV pole during installation. If the operator does not hold onto the IV pole while pressing the IV pole release button, the IV pole may drop in a free fall. If the operator’s hand or any other body part is in the path of the free-falling IV pole, the operator could be injured. Because this is an added safety feature, do not remove the collars after they are installed on the IV pole.
Remedy Action:	Your local Terumo BCT representatives will work with you to ensure IV pole collars are provided and installed on Trima Accel systems already in the field. On new machines, service technicians will attach the IV pole collar to the IV pole during installation.
Athorized Representative/Importer/Distributor:	ABDULREHMAN AL GOSAIBI GTB
Report Source:	NCMDR
Source Ref. Number:	5275ED261E1F8
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Terumo BCT (Trima Accel).pdf

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