Alerta De Seguridad para MultiFiltrate devices using software version 5.2

Safety alert

2013-09-17

2013-09-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130917.html

Medical device safety alert: fresenius medical care multifiltrate devices using software version 5.2 the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning all multifiltrate devices using software version 5.2 manufactured by fresenius medical care ag & co. kgaa. the manufacturer has become aware of a software error when using the substitution bolus function during a continuous renal replacement therapy (crrt) treatment. in one case the substitution bolus unintentionally did not stop after 100 ml. in the worst case, a started substitution bolus is not controlled and automatically stopped by the machine and continues until manually stopped by the user. this situation can lead to severe volume overload and subsequently cause a serious health deterioration or even death. the manufacturer will provide the users with software update as soon as possible. meanwhile, users are strongly recommended to stop using the substitution bolus functionality. in case a fluid bolus is required during crrt, it is recommended that users should use the same process as applied in non-crrt treated patients, e.G. direct infusion of a suitable infusion solution. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con314890 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2013.