Loading MedWatcher information…
100 results
FDA · FDA event 97296
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement…
Posted Aug 29, 2025
FDA · FDA event 97003
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to…
Posted Aug 27, 2025
FDA · FDA event 97079
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an…
Posted Aug 19, 2025
FDA · FDA event 97164
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level…
Posted Aug 14, 2025
FDA · FDA event 97166
Potential for the manometer port being blocked rendering the manometer non-functional.
Posted Aug 13, 2025
FDA · FDA event 97191
Devices may possess a programming error resulting in an incorrect device configuration.
Posted Aug 8, 2025
FDA · FDA event 97067
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Posted Aug 6, 2025
FDA · FDA event 97186
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Posted Aug 6, 2025
FDA · FDA event 97072
Certain Spectrum infusion pumps may have an incorrect version of software.
Posted Jul 17, 2025
FDA · FDA event 96948
This device does not indicate for use in patients with respiratory failure.
Posted Jul 2, 2025