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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 165 07 13 002
Analyser, blood gas , pCO2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
Pco2 Membrane Box (D788), used on ABL700 and ABL800 series analysers
Medical Device Identifier:
R338 to R493; part 942-063, pCO2, D788 Membrane
Update code from MHRA: Select one of the Quality Control products listed below to be used for pCO2 verification: Qualicheck3+: S7330 (Level 1) Autocheck3+: S7335 (Level 1) Please see the attachment
Reason of Field Safety Corrective Action:
RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. The Bias can be seen after the replacement of the membrane, and will be positive in the low range and negative in the high range. There is a risk of wrong diagnosis and maltreatment of patients for biased measurement results in the high range , Root cause investigation is still in progress, but the preliminary root cause is variations in the thickness of a silicone layer used in the membrane units. The error was discovered through internal testing on blood and QC material in connection with a CAPA raised to document the investigation of an issue regarding low QC comparison results.
BfArM update Action:
Your local Radiometer representative has now installed the improved sealing ring for the pH electrode in your ABL700 and ABL800 Series Analyzers. The improved sealing ring may be identified by its blue color.
The procedure instructs customers to manually adjust the QC ranges for one of three QC products, and immediately perform one quality control measurement on already installed membrane units to verify the pCO2 performance. Also, until further notice the performance of membrane units must be verified by running a QC with decreased ranges after installation. The customer is urged not to report pCO2 results unless the membrane unit has been verified as described, and instructed to re-evaluate relevant patients as previous pCO2 results could also be affected.
Salehiya Trading Est. , Riyadh , (011)-2628939
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.