Saudi Food and Drug Authority warns that an important safety information regarding specific models of the SV0.5 FOLFusor and SV 0.5 lnfusor Elastomeric Infusion Pumps, has been issued2015-05-26
Saudi Food and Drug Authority would like to warn all healthcare practitioners that Baxter Healthcare company, the manufacturer of these disposable lnfusor Elastomeric infusion pumps designed for use in delivering liquids through intravenous., is issuing important safety information regarding specific models of the SV0.5 FOLFusor and SV 0.5.Those pumps are non-electronic, ambulatory and are used to administer analgesics, cytostatics, antibiotics, and some other medicines to patients.
SFDA has become aware through Baxter Healthcare that they are issuing safety information regarding the Elastomeric Infusion Pumps- table 1. The letter is to inform healthcare practitioners that the direction insert states that infusion rates may be up to 10% greater than the nominal (labelled) infusion rate of 0.5mL/hr, a recent review of flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal (labelled) infusion rate. This can lead to deliver medication at a faster rate than intended that may result in toxicity and changes to efficacy that require medical intervention.
Saudi Food and Drug Authority recommends all healthcare practitioners to adhere to the following :
- Follow the device Instructions for Use which explain the following factors that may impact resulting flow rate. These factors can contribute to infusion rates in excess of 30% greater than the nominal (labelled) flow-rate:
• The choice of medication: Refer to the drug manufacturer’s package insert for drug reconstitution/dilution and storage procedures.
• Instructions for calculating the correct fill volumes, including the potential for increase in flow rate, which may result from a fill volume below the stated nominal (labelled), fill volume.
• Temperature change, as flow rate will decrease approximately 2.3% per 1°C decrease in temperature and will increase approximately 2.3% per 1°C increase in temperature.
• Choice of the diluents (5% Dextrose vs. 0.9% Sodium Chloride) e.g., a ~10% increase in nominal flow rate may result when 0.9% Sodium Chloride is used.
• Nominal flow rate of the INFUSOR is realized when the Elastomeric Reservoir and the Distal End Luer Lock are positioned at the same height.
• Flow rate will decrease ~0.5% for every inch the Elastomeric Reservoir is positioned below the distal end luer lock and increase ~0.5% for every inch the elastomeric reservoir is positioned above the distal end luer lock.
• Consider: Length, diameter, and location of catheter.
- For more details, call Baxter Healthcare customer services on +966 11 4343 714.
- Distribute and disseminate of information contained in this warning to all concerned.
Saudi Food and Drug Authority encourages all to report any adverse event associated with medical devices through the national center for medical devices reporting
For more information please visit the Saudi Food and Drug Authority website :