EXACTAMIX Compounder EM2400 and EM1200 의 안전성 경고

Safety alert

2013-08-27

2013-08-27

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130827a.html

Medical device safety alert: baxter healthcare exactamix compounder em2400 and em1200 medical device manufacturer, baxter healthcare ltd, has issued a medical device safety alert concerning the exactamix compounder em2400 and em1200, display module 2400- dy and 1200-dy. baxter has received customer complaints regarding exactamix compounders experiencing an intermittent reset of the internal clock contained within the exactamix compounder display module with part numbers 2400-dy and 1200-dy. this issue only affects the dy display modules. this condition is the result of the battery life being less than anticipated and impacting the internal clock of the compounder. this battery failure results in failure of the exactamix system to alert the user to replace the disposable set after 24 hours of use. users should not rely on this alert to trigger the daily replacement of disposable sets. because daily replacement of disposable sets is standard practice, no adverse health consequence is reasonably expected to result. potential hazards which could result if the disposable sets are not replaced daily include microbial contamination and particulate matter. there have been no reported patient injuries or adverse events associated with this issue. the manufacturer reminds users that confirming the correct time and date is a best practice, and should be performed at the setup of each use. the manufacturer also recommends users to create and review the authorization report daily, which will allow users to confirm their compounder has the correct time and date. in addition, the manufacturer will arrange a swap-out of the current display model with a unit that has had a correction applied. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 27 august 2013.