Medical device manufacturer, Gambro, has issued a field safety notice concerning Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02.
The manufacturer reminds users of the possibility that foam may be formed in the venous blood circuit when the extracorporeal circuit is primed using on-line priming.
The priming volume specified in the Operator's Manual and in the dialyzer Instruction for Use may not be sufficient to completely eliminate any air trapped in the dialyzer fibres. When this occurs, some foam may be created in the venous circuit during patient connection and during the first few minutes of treatment. The condition is visible to the operator. The potential hazard would be presence of some foam in the venous patient line.
The air bubble detection system is designed to stop the blood pump when macro bubbles greater than 20 μL are detected. The presence of operator also reduces the risk of foam reaching the patient.
According to the local supplier, only the Artis Dialysis System is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 January 2015