Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 00804/13

The company Nikkiso Deutschland GmbH notified on 2013-01-15 of an Update regarding the Field Safety Corrective Action for the Hemofiltration Device AQUARIUS (regular platform 6). Field Safety Notices were sent to customers warning them about the risk when repetitive clearing the balance alarm without solving the cause. A software solution version 6.02 for systems without citrate option has been completed to prevent such a proceeding, which will be implemented in the next months.

In an update of 2014-01-07 for Aquarius Regional Citrate Anticoagulation (RCA) systems the manufacturer notified affected users of a software solution to the issue.

Safety Corrective Action for the Hemofiltration Device AQUARIUS (regular platform 6), Nikkiso Deutschland GmbH , Download_VeroeffentlichtAm_EN 2014.02.07 PDF, 4MB, File does not meet accessibility standards