GoPump and GOBlock Rapid Recovery System kits 의 안전성 경고

Safety alert

2013-05-20

2013-05-20

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130520b.html

Medical device safety alert: symbios medical products gopump and goblock rapid recovery system kits the united states food and drug administration (fda) has posted a press release issued by symbios medical products concerning their gopump and goblock rapid recovery system kits. according to the press release, the manufacturer initiated a voluntary recall of all gopump rapid recovery system kits and goblock kits manufactured with flow control components assembled prior to jul 2012. products subject to this recall were distributed between 1 apr 2011 and 30 apr 2013. these products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.G., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. to date, there have been 5 complaints received, two of which involved serious consequences. there have been no patient deaths reported. the root cause is understood and processes have been put in place to address the issue. for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm352627.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2013.