Sedana Medical AnaConDa 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2006/045

CON2024462

2006-08-09

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2024462

Risk of anaesthetic overdose. the mhra is aware of an adverse incident that occurred at the beginning of 2005 during the use of an anaconda. it is believed that the adverse event was caused by a combination of user error and inconsistencies in the instructions for use. sedana medical have taken over as the manufacturer of the anaconda and corrected these inconsistencies. the current version of the instructions for use is ifu 7 691 300-r001, published in july 2005 (available at www.Sedanamedical.Com (external link)). sedana medical is implementing changes to the design of the system to eliminate the luer connection between the syringe and the anaconda and is making additional changes to the instructions for use. sedana medical estimates that these changes will be introduced on new products at the end of 2006.

Check that there are procedures in place to ensure that the AnaConDa device is only used: according to the current version number of the instructions for use (At the time of publishing this is version number 9 691 300-R001, issued in July 2005) by clinicians specifically trained in the use of anaesthetic drugs with the correct level of monitoring and respiratory support, as recommended by the AAGBI (Recommendations for standards of monitoring during anaesthesia and recovery, 3rd edition, 2000).