BD Phoenix™ System Software and BD Phoenix™ Update Disks 의 안전성 경고

Safety alert

2012-04-30

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120430b.html

Field safety notice: bd phoenix™ system software and bd phoenix™ update disks medical device manufacturer, bd. has initiated a field safety corrective action concerning certain bd phoenix™ system software and bd phoenix™ update disks. according to the manufacturer, through customer feedback and subsequent investigation by their in-house technical experts, they have identified an increase in vancomycin-resistant enterococcus faecium strains that may exhibit erroneous results (false susceptible or false intermediate interpretations) in the vancomycin well on all pmic or pmic/id panels.  these strains of e. faecium show different growth patterns in the phoenix system than those previously identified. all gram positive panels containing vancomycin are affected by this action therefore this notice is applicable to all current and future product lots that contain vancomycin until further notice. this issue is related only to ‘vancomycin susceptible or vancomycin intermediate’ e. faecium results.  all ‘vancomycin resistant’ results for e. faecium and all mic results for organisms other than e. faecium continue to be interpreted correctly. at the time being, an epicare rule will be installed by bd to suppress vancomycin susceptible and vancomycin intermediate results for e. faecium from being reported to lis. a more permanent software solution is being developed to address the issue. according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.