Shared on behalf of Quality and Risk Management
Please share with applicable staff.
Please be advised that Baxter Corporation has issued an urgent medical device correction for our current intravenous (IV) pump, the Novum IQ Large Volume Pump (LVP). Baxter has provided the following information:
1. Under-infusion when moving from low to high flow rate
Under-infusion may occur when transitioning from a lower to a higher flow rate, specifically
when the second flow rate is more than double the first flow rate. In the worst case, no
delivery may occur.
Baxter is working to identify software and/or hardware corrections to address the issue
2. Potential for over- and under-infusion that may be due to set misloading.
Failure to load the tubing properly into the pump channel may result in the pump infusing at a
rate higher or lower than programmed.
Baxter is developing a hardware change to reduce misloading of the set.
Mitigation Strategies
Health care providers can continue to use the Novum IQ LVP while following the instructions
listed below:
Ensure:
a. The door is fully open before loading the set.
b. The tubing is taut and loaded without slack in the pumping channel, as in Figure 1
below.
c. Monitor patients frequently to ensure that the appropriate infusion is being
delivered.
If under-infusion or over-infusion occurs while using the Novum IQ LVP, please take the
following actions:
- Immediately remove the pump from use and label “out of service”
- Complete a biomedical requisition and attach to the pump (include asset number
located at the top of each pump, e.g. “2022B10251”). - Complete an Incident Learning System patient safety incident report and reference the
biomedical requisition number. - Notify and bring the pump to your Manager.
We appreciate your efforts and cooperation in these extra steps to ensure patient safety.