Device product
Novum IQ Syringe infusion system, Product Code 40800BAXUS
Z-0151-2024
Product summary
- Event
- Event 93191
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2023 units
- Official record key
device-enforcement:Z-0151-2024
Official wording
Reason: Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.
Code information: All Serial Numbers
Distribution pattern: US Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, PA, TX, UT, VA, VT, WA, WI AND WV.
Derived failure modes
-
Unknown
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though uninfused fluid remains in the syringe.