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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 002 05 11 000
Date submitted: 5/1/2011
Manufacturer:Radiometer Medical
Device Type:Blood gas analyzers
Description:The machine used for analysis aspirates blood from the syringe and measures the pH and the partial pressures of oxygen and carbon dioxide. The bicarbonate concentration is also calculated.
Medical Device Identifier:ABL505/555, EML105, ABL600, ABL700 Series, ABL800. Serial no.: 942-046 and 946-060. Potentially all lots.
Reason of Field Safety Corrective Action:RADIOMETER recently became aware that wrinkles might arise on the outer membrane of these membrane units upon installation. Retention of fluids between the wrinkles can cause a positive bias of approx. 14% when measuring on whole blood at a level of approx. 0.80 mmol/L.
Remedy Action:Action to be taken by the user: 1. Remove and discard the existing Ca membrane 2. Fill a small beaker with rinse solution (for the analyzer in question) 3. Click the electrode into the new membrane unit 4. Immerse the membrane into the beaker with rinse solution for five seconds and move the electrode from side to side (“stir”) (this softens the membrane and prevents wrinkles) 5. Remove droplets of rinse solution on membrane 6. Install the electrode in the analyzer 7. Wait for the analyzer to complete calibration 8. Verify the Ca performance using one of the QC solutions listed below 9. If the Ca verification fails the membrane must be replaced
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-2011-04-26 - 006
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Radiometer Medical.pdf