UK MHRA has issued a Medical Device Alert (MDA) on the Aquarius Haemofiltration Device manufactured by Nikkiso Europe GmBH and distributed by Baxter Healthcare, following 8 reports of breakage.
The alert can be found here and details a problem with the wheels of the unit such that under certain circumstances they can work loose or break and as a consequence render the unit unstable.
The manufacturer issued a Field Safety Notice in September, but has not receieved enough confirmations from customers that they have received and acted on the information. Consequently this MDA has been issued.
The manufacturer has issued instructions regarding the movement of the device, which are included in the MDA, and confirmed that service engineers will be checking the condition of all potentially affected Aquarius units in the field.
Source: MHRA
published: October 31, 2011 in: Alerts/Adverse Events, Baxter, Regulatory