Novum IQ Large Volume Pump - Important Safety Updates

Important Safety Updates

Products affected:

Licence name: Novum IQ Large Volume Pump
Device Identifier: 40700BAX
Medical Device Licence Number: 104574
Market Authorization Holder: Baxter Corporation

Key messages:

Since 2021, various safety risks associated with Baxter’s Novum IQ Large Volume Pump (LVP) have been identified and communicated by Baxter to users.
The information on this page is intended to provide a comprehensive and up-to-date overview of key information previously communicated by Baxter, and to provide users with recommendations to minimize risks.
In addition to the remediation steps described in the table as well as each Customer Letter, healthcare professionals should:
- Adhere strictly to the Operator’s Manual (see the latest version available on the Baxter Technical Service Portal);
- Be on the lookout for any pump performance failures and, in particular, the issues described in the table below;
- Have a backup pump available, where possible; and
- Report any incidents to Health Canada and to Baxter.

Background information

The Novum IQ LVP is used in healthcare facilities for the controlled administration of fluids including pharmaceutical drugs, parenteral nutrition, blood and blood products through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous and epidural.

There have been reports of Novum IQ LVP device failures as a result of design, software, and quality control issues. Some of these reports have resulted in urgent communications from Baxter to users (with corresponding recall notices posted on the Government of Canada's Recalls and Safety Alerts Database).

These risks can lead to potentially serious patient injury or even death under critical situations. To date, Baxter has received 7 reports of patient injury associated with the use of the Novum IQ LVP, including 2 reports of a serious injury potentially associated with internal screws becoming loose within the device. No reports of death have been received.

Please refer to the Customer Letters via the links provided in the table below for full details of each issue.

Summary of Product Safety Information:

The table below lists the up-to-date safety information related to Novum IQ LVP devices, previously communicated by Baxter, including the potential clinical impact and recommended remediation steps

Date	Product	Category and References	Issue Description and Risks	Potential Clinical Impact	Remediation
09/15/2022 and 02/06/2023 and 12/20/2023	Novum IQ LVP	Urgent Medical Device Safety Alert and Urgent Medical Device Correction Customer Letter 1 Customer Letter 2 Customer Letter 3 Health Canada Recall Alert RA-64580	Over-infusion at flow rates below 0.5 mL/hr for the general population, and at flow rates below 1 mL/hr with neonates when using 2R administration sets.	This issue may lead to the hazardous situation of overinfusion at flow rates less than 0.5 mL/hr for general population, and less than 1 mL/hr for neonates when using 2R administration sets.	1. When the correction becomes available, a local Baxter representative will contact your facility. Your facility will be receiving this correction from Baxter at no charge. Baxter will work with your facility to ensure the safe and timely correction of all devices. 2. Prior to the correction, the following Risk Mitigations should be implemented: For the general population, use a flow rate ≥ 0.5 mL/hr for all administration sets For use of 2R administration sets with neonates, use a flow rate ≥ 1 mL/hr Consider use of an alternative pump (e.g. syringe pump) for flow rates outside these conditions If you need to use the Novum IQ LVP at a flow rate outside of the limitations described above then, ensure the IV administration set changes occur at 24-hour intervals. Immediately discontinue use of the incompatible set (product code 1W5000) with the Novum IQ LVP. Contact a Baxter Clinical Representative, or Baxter Medical Information at 1-855-584-1368 or [email protected] to discuss an alternate compatible set option.
10/26/2023	Novum IQ LVP	Safety Alert Customer Letter Health Canada Recall Alert RA-74555	Potential for a keypad to malfunction. Specifically, when a pump operator presses a single key on the keypad, the pump may incorrectly register multiple keys. This is applicable to all Novum IQ large volume pumps. Baxter continues to actively investigate this specific issue.	The following may occur if user fails to visually verify that entries (drug concentration, dose mode, dose rate, and time) made on the keypad were correctly registered on the pump display: Excessive therapy Insufficient therapy Delay in therapy Interruption in therapy	Healthcare providers may continue to use Novum IQ Large Volume Pumps while following the Instructions for Use. In addition, the following must be confirmed by the pump operator prior to starting an infusion or initiating a drug titration: i. Visually verify that entries (drug concentration, dose mode, dose rate, and time) made on the keypad were correctly registered on the pump display. ii. Pay additional attention to drug limits, hard, soft and change limits triggered when programming and verify infusion parameters.
08/08/2023	Novum IQ LVP	Urgent Medical Device Correction Customer Letter Health Canada Recall Alert RA-74111	Malfunctioning keypads that may incorrectly register multiple keys upon a single keypress; This Field Action applies only to a subset of Novum IQ LVPs, which were manufactured with one specific keypad production lot.	The following may occur if user fails to visually verify that entries (drug concentration, dose mode, dose rate, and time) made on the keypad were correctly registered on the pump display Excessive therapy Insufficient therapy Delay in therapy	Specific Novum IQ LVPs with impacted serial numbers, as identified in the Customer Letter, and any devices that have malfunctioning keypads should be removed from use. Baxter is contacting all affected customers and will be providing immediate replacements based on need. If continued use of the pump is necessary because no spare pump is available, then the following must be confirmed by the pump operator prior to starting an infusion or initiating a drug titration: i. Visually verify that entries (drug concentration, dose mode, dose rate, and time) made on the keypad were correctly registered on the pump display. ii. Pay additional attention to drug limits, hard, soft and change limits triggered when programming and verify infusion parameters.
07/26/2023	Novum IQ LVP	Urgent Medical Device Correction Customer Letter Health Canada Recall Alert RA-74047	Potential for internal screws becoming loose that can damage the pumping mechanism valves, leading to delivery accuracy issues.	Overinfusion Delay in therapy An interruption of therapy An electrical hazard	Prior to using a Novum IQ LVP, confirm pumping mechanism valves are not stuck and are moving up and down as the door is rotated open and shut. If the mechanism valves are stuck or not moving up and down with the rotation of the door, immediately discontinue the use of the device. In certain cases, a screw that has become loose inside a pump could result in a rattling sound when the pump gets transported or otherwise moved. If an atypical sound is heard - such as a rattling sound - coming from inside a pump that is being moved or transported, immediately discontinue the use of the device. Baxter will be contacting customers to arrange replacement with corrected pumps.
05/29/2023	Dose IQ Safety Software	Urgent Medical Device Correction Customer Letter Health Canada Recall Alert RA-73759	A defect in the Dose IQ Safety Software (used with Novum IQ LVP) resulting in an invalid initial setting for the air-in-line threshold.	Delay in therapy Interruption in therapy Unexpected bubble size (between 100 and 200 µL) potentially passing to the patient	For users that have previously migrated libraries from Spectrum IQ to Novum IQ LVP, operators may continue to use the Dose IQ Safety Software by taking the steps described in the Customer Letter. Baxter will be contacting customers to upgrade their pumps once the software upgrade is available.
10/20/2022 and 12/07/2022	Novum IQ LVP	Urgent Medical Device Correction Customer Letter 1 Customer Letter 2 Health Canada Recall Alert RA-72081	Software issues resulting in the following: A failure to execute bolus initiations/cancellations or titration adjustments as expected by the user. An unexpected screen transition during the ‘air still detected’ alarm workflow. Incorrect reported delivered volume while an infusion is running.	Interruption of therapy Insufficient therapy Excessive therapy Patient exposure to air in line and/or interruption of therapy	Immediately upgrade all Novum IQ LVPs to software version 1.1.6 found on the Baxter Technical Service Portal. All Novum IQ LVPs shipped after December 2022 have software version 1.1.6 installed. As of November 2023, 99% of affected units in the field have been upgraded to software version 1.1.6.

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Novum IQ Large Volume Pump - Important Safety Updates