Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning INFUSOR, FOLFUSOR, and INTERMATE portable elastomeric infusion systems manufactured by Baxter Healthcare SA. All lots are affected.

Baxter has received complaints for infusion flow rates greater than intended for the above portable elastomeric infusion systems. In many cases, the complaint details an overinfusion of medication that is the result of uses inconsistent with the Instructions for Use (IFU).

As delivery of medication at an infusion rate faster than intended may lead to toxicity or changes to efficacy that require medical attention, Baxter is requesting that healthcare providers continue to follow the device IFU which explains the following factors that may impact resulting 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 fill volume.
• Temperature change on the device.
• Choice of the diluents (5% Dextrose vs. 0.9% Sodium Chloride) as a ~10% increase in nominal flow rate may result when 0.9% Sodium Chloride is used.
• The position of the Elastomeric Reservoir in relation to the Distal End Luer Lock. 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.
• Length, diameter, and location of catheter.

For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON316301

According to the local supplier, the affected products were distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 2 October 2013