Medical device manufacturer, Baxter Healthcare, has issued a medical device safety alert concerning its Colleague Single Channel CXE, Colleague Triple Channel CXE, EVO IQ LVP and EVO IQ SYR. The affected devices are identified as the following: -
In response to clinical practice changes during the COVD-19 pandemic, the manufacturer is communicating important safety information regarding the practice of using multiple extension sets with infusion pumps. It should be noted that increasing the length of IV tubing between the pump and the patient will result in varying increases in outlet pressure and/or decreases in intake pressure, which could lead to unknown and undetectable reductions in forward flow and flow rate accuracy. To date, the manufacturer has received one report of serious injury related to the use of multiple extension sets and improper hanging height.
According to the manufacturer, the use of multiple extension sets may lead to flow rate or titration inaccuracies which may subsequently result in over infusion, under infusion, delay or an interruption in therapy. Any potential harm to the patient would depend on several factors such as length of delay or interruption in therapy, the volume and rate of the infusion, patient status, and comorbidities. Additionally, use of multiple extension sets could increase the opportunity for accidental disconnections and could result in infusion of contaminated IV fluids and/or blood loss. Any potential harm to the patient from such accidental disconnections would depend on several factors, such as the type and content of the IV fluid, type of IV access, and whether contamination occurs before or at the point of care.
The manufacturer is instructing affected users to refer to the warnings and instructions in the product-specific Operator's Manual.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary action.
Posted on 19 March 2021