It has come to our attention that medical device manufacturer, CareFusion has issued a field safety notice regarding the Alaris GP Infusion System with the following model numbers: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G.
The manufacturer through its post market surveillance system learned that the Alaris GP Infusion System produces very small air bubbles (less than 50 μl) which are too small to trigger the lowest configurable air-in-line detection thresholds (alarm) of the Alaris GP Infusion System being 50-500 μl as configured by the user or 1ml over a rolling 15 min. window (which is considered state of the art and in compliance with EN 60601-2-24: Particular requirements for the safety of infusion pumps and controllers)
The air bubbles appear to be generated within the fluid path of the (porous) silicone pumping segment of the administration set during an infusion. The volume and frequency of air bubbles being generated during infusions is influenced by the rate of the infusion, by the height of the pump above the patient and the extent of degassing of drugs. Once generated the air bubbles are then transported with the infusion fluid and will generally be delivered to the patient.
A bolus of air into the vascular system may result in pulmonary (venous) air embolism or arterial air embolism. This is believed to put patients with a clinical condition referred to as atrial septal defect at elevated risk.
The manufacturer is not aware of any reports of fatal venous or arterial air embolisms that occurred during the use of affected product having functional air-in-line detectors. This suggests that the affected product provides sufficient protection from an air embolism.
The remote but unacceptable potential for a death or serious injury however suggests that action is justified to prevent further use of affected product without users considering additional safety precautions to elevated risk detailed in the specific clinical condition.
The manufacturer advised users of the Alaris GP Infusion System to follow the new instructions and warnings in the DFU content and thus the use of a CareFusion administration set with an air filter or a standalone filter for the patient group diagnosed with atrial septal defect.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 14 November 2012