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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 154 07 18 000
Date submitted: 7/31/2018
Manufacturer:Terumo Cardiovascular Systems Corporation
Device Type:CDI Blood Parameter Monitoring System 500 H/Sat Probe Assembly
Description:Continuous blood
parameter monitoring
for improved blood
gas management
Medical Device Identifier:HSat Probe Assembly, CDI 500 : 145883

Monitor with one Blood Parameter Module and one HSat Probe : 500AHCT

Monitor with two Blood Parameter Modules and one HSat Probe : 500AVHCT
Reason of Field Safety Corrective Action:specific subset of the H/Sat Probe Assembly population is being withdrawn due to a supplied component in the optics, the Optical Module. A change by the supplier to a different material and anodization resulted in increased failures. H/Sat Probe Assemblies are used in production and in service. The CDI System 500 Monitor conducts an automated self-test when the device is powered on. If the monitor contains an affected component, a color chip test failure will occur and the H/Sat probe will be disabled.
Remedy Action:This communication is to alert you of this issue and to request the return of your affected CDI System 500 Monitor. To schedule the return, contact Terumo CVS Customer Service (1.800.521.2818) to request a Returned Goods Authorization. The Terumo CVS Ann Arbor service depot will replace the affected H/Sat Probe Assembly.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:F2098F824E25A
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Terumo Cardiovascular Systems Corporation.pdf