CDI™ 500 Blood Parameter Monitoring System 의 안전성 경고

Safety alert

2012-03-09

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120310b.html

Field safety notice: terumo cdi™ 500 blood parameter monitoring system medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice concerning cdi™ 500 blood parameter monitoring system. in a recent review of in-house service procedures for the cdi™ 500 blood parameter monitoring system, terumo cardiovascular systems (terumo cvs) determined that replacement of the batteries should be considered “routine maintenance”. currently, system batteries that are 10 years old or older will be replaced by service technicians when a system is sent to terumo cvs for service. the current operator’s manual for the cdi 500 system does not list any routine maintenance procedures for the system. therefore, some systems may be relying on system batteries beyond their useful life. in this case, error codes may appear, and the system is at risk of losing information. there have been no reports of patient injury as a result of this issue. terumo cvs is now revising the operator’s manual for the cdi 500 system to remind operators to replace the system batteries every 10 years. according to the local supplier, affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.