Early Alert: Infusion Pump Issue from Baxter
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Baxter has issued a letter to affected customers recommending all Novum IQ Large Volume Pumps (LVP) and Novum IQ Syringe Pumps (SP) be corrected prior to continued use:
| Product Code | Product Description | Serial Numbers | UDI-DI Number |
|---|---|---|---|
| 40700BAXUS | Novum IQ LVP | All | 05413765851797 |
| 40800BAXUS | Novum IQ Syringe Pump | All | 05413765852428 |
What to Do
While providing patient care involving high-risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient’s treatment. Customers can continue to use the Novum IQ LVP and Novum IQ Syringe Pump while following the instructions listed below.
On August 4, Baxter sent all affected customers a letter recommending the following actions:
- Users should rely on their clinical judgment. When providing patient care involving high risk medications and/or critical illness, users should consider utilizing an alternate pump, if available and appropriate for the patient’s treatment.
- If an alternate pump is not available or appropriate for patient care involving high risk medications and/or critical illness, you may continue to use the Novum IQ LVP and Novum IQ Syringe Pump consistent with the following actions:
- If a blank Run screen is displayed during an infusion on the Novum IQ LVP, the user should open the door, press the tubing into load point 3, then load point 4, to turn the light green (pictured in Figure 1 below), and close the door. If a blank Run screen is displayed during an infusion on the Novum IQ Syringe Pump, the user should unload, then reload the syringe. If these actions do not resolve the blank screen, both LVP and Syringe Pump users should power-cycle the pump, select “Yes” to the new patient prompt, and reprogram the infusion (See Figure 1 below).
- To prevent a false motor movement system error, do not program the Novum IQ syringe pump to infuse below the Minimum Recommended Flow Rate for a syringe size of 10 mL or greater (See Attachment A below for more information).
- Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification.
- Please forward a copy of this communication to the chief medical officer, medical director, director of anesthesia, facility risk manager, director of purchasing/central supply, and any other departments within your institution who use the affected product.
- Print and post Attachment A in areas frequented by potential users (e.g., break rooms) and where pumps are stored.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Attachment A: Movement Rate Change Failures
Baxter Healthcare has issued an Urgent Medical Device Correction for Novum IQ Syringe Pump due to false motor movement system errors. Baxter has identified a software anomaly that results in a false motor movement system error (error code 20602 or 20603). The error can occur only after the user completes specific dose or flow rate changes as identified in this Attachment A, when running below the minimum recommended flow rate on a syringe size of 10mL or greater. Specifically, when using a syringe identified in the “Compatible Intravenous Syringes” column, the system error will occur if the user changes the programmed flow rate from the rates identified in the “Initial Rate” column to the corresponding rate in the “New Rate” column.
| Compatible Intravenous Syringes | Initial Rate (mL/hr) | New Rate (mL/hr) |
|---|---|---|
| BD 10 mL | 0.07 | 0.06 |
| BD 30 mL | 0.11-0.12 | 0.1 |
| BD 50 mL | 0.1-0.12 | 0.13 |
| BD 50 mL | 0.13-0.14 | 0.12-0.1 |
| BD 50 mL | 0.15 | 0.12-0.11 |
| BD 50 mL | 0.16 | 0.12 |
| BD 50 mL | 0.17-0.19 | 0.16-0.15 |
| BD 50 mL | 0.2 | 0.16 |
| BD 50 mL | 0.21-0.24 | 0.2 |
| Monoject 12 mL | 0.08 | 0.07 |
| Monoject 35 mL | 0.14-0.15 | 0.13-0.12 |
| Monoject 35 mL | 0.16 | 0.13 |
| Monoject 35 mL | 0.17-0.19 | 0.16 |
| Monoject 60 mL | 0.21-0.24 | 0.2 |
| Compatible Enteral Syringes | Initial Rate (mL/hr) | New Rate (mL/hr) |
|---|---|---|
| BD Enteral 10 mL | 0.07 | 0.06 |
| Baxter/Neomed Enfit 12 mL | 0.08 | 0.07 |
| Baxter/Neomed Enfit 20 mL | 0.13-0.14 | 0.12 |
| Neomed Enfit 35 mL | 0.13-0.15 | 0.12 |
| Neomed Enfit 35 mL | 0.17-0.19 | 0.16 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.1-0.12 | 0.13 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.13-0.14 | 0.12-0.1 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.15 | 0.12-0.11 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.16 | 0.12 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.17-0.19 | 0.16-0.15 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.2 | 0.16 |
| BD Enteral 50 mL and Baxter Enfit 60 mL | 0.21-0.24 | 0.2 |
| Neomed Enfit 60 mL | 0.1-0.12 | 0.13 |
| Neomed Enfit 60 mL | 0.13 | 0.12-0.1 |
| Neomed Enfit 60 mL | 0.14 | 0.13-0.1 |
| Neomed Enfit 60 mL | 0.15 | 0.12-0.11 |
| Neomed Enfit 60 mL | 0.16 | 0.12 |
| Neomed Enfit 60 mL | 0.17-0.19 | 0.16-0.15 |
| Neomed Enfit 60 mL | 0.2 | 0.16 |
| Neomed Enfit 60 mL | 0.21-0.24 | 0.2 |
Reason for Early Alert
Baxter has issued an Urgent Medical Device Correction for their Novum IQ Large Volume Pumps (LVP) and Novum IQ Syringe Pumps (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
The blank Run screen (LVP and SP) occurs with multiple software anomalies. For example, this issue can occur when a user attempts to silence a downstream occlusion (DSO) alarm at the same time the device is automatically restarting the infusion (i.e., clearing the alarm condition). A blank Run screen on either the Novum IQ LVP or SP will not interrupt the ongoing therapy, which will continue to run to completion, but the user will not be able to adjust the ongoing therapy. An interruption of therapy will be required should the user need to adjust therapy settings. Excessive or insufficient therapeutic effects may occur in the interim period while either the pump door is opened or closed while the infusion is running (LVP); the syringe is reloaded while the infusion is running (SP); the pump is power cycled; or the pump is replaced.
Regarding the false motor movement system error (SP only), Baxter has identified a software anomaly in the Novum IQ Syringe Pump that results in a false motor movement system error (error code 20602 or 20603). The error can occur only after the user completes specific dose or flow rate changes (as identified in Attachment A of the Urgent Medical Device Correction Letter) when running below the minimum recommended flow rate on a syringe size of 10mL or greater. The false motor movement system error will cause an interruption of therapy, which may lead to significant adverse health consequences, including serious injury or death, depending on the medication being infused and the vulnerability of the patient.
As of July 21, Baxter has received three reports of serious injuries and no reports of death associated with these issues.
Device Use
The Baxter Novum IQ LVP and Novum IQ Syringe Pump are intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at corporate_product_complaints_round_lake@baxter.com or 1-800-843-7867 (select option 2, then option 2 again).
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