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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 001 02 11 000
Date submitted: 2/1/2011
Manufacturer:Radiometer Medical
Device Type:Blood Gas Analyzers - ABL90 FLEX
Description:Metabolic profile clinical chemistry analyser IVD, stationary, automated

Medical Device Identifier:ABL90 FLEX and accessory SC90 946-008 sensor cassette Software version: 2.4.1680.25 Lot/batch no.: R0031
Reason of Field Safety Corrective Action:(in January 27 , 2011 ) Sensor cassette 946-008 lot R0031 has been found to exceed specifications for the parameters pH, K, Na, Ca and Cl. The error resembles a positive bias on the reference electrode, increasing in size from installation of the cassette. The resulting parameter bias is of the order of 9 mmol for sodium, 0,1 mmol for Calcium, 0,2 mmol for Potassium, -0,018 for pH and -7 mmol for Chloride. Two incidents regarding lot R0031 were reported from the field, one from Belgium (Radiometer ref. RBNL 576990103) and one from Finland (Radiometer ref. TRIO 579829752). No reports of death or serious injury were received, but the chemist at the Finnish hospital suspects that patients could have been maltreated. The clinical risk assessment of the Belgian incident states that the error could lead to clinical serious misinterpretation and mal-therapy in the critical care setting if it should happen again.
Remedy Action:The affected lot R0031 is recalled from the market. Separate customer letters are issued to customers
Athorized Representative/Importer/Distributor:Salehiya Trading Est. , Riyadh , (01) 4633205
Report Source:http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
Source Ref. Number:DK-2011-01-27 - 002
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments