Health Canada — Medical Devices · Canada · 2014-04-30 · Type II
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Reported risk: Baxter Corporation is issuing a safety alert for coiled tube infusors noting that a labeling error, previously communicated to customers on March 5, 2014, when combined with all other use factors, can contribute to infusion rates in excess of 30 percent greater than the nominal (labeled) flow rate. Delivery of medication at an infusion rate faster than intended may lead to toxicity and changes to efficacy that require medical intervention.
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