Baxter Healthcare Corporation Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned patient protocols (bed exit, siderail position, brakes off, height of bed changes, head of bed angle, and/or turn reminders) are turned off.

Recommended Action

Per FDA guidance

Baxter issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/19/2023 by letter (USPS). The notice explained the issue, hazard, and requested the following: Baxter is asking that you take the following actions: 1. Share this letter with your IT department (or other relevant personnel) to determine if you have the impacted software version and contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week, to schedule a software upgrade which addresses the identified issue. 2. You may continue to use your Voalte Patient Safety Software (VPS) (with your Centrella bed) until a software upgrade is completed by implementing either of these options into your clinical bedside workflow: Option 1: When working with a patient in the room, and a bed exit alarm is activated, only silence the bed, and extend the silence timer instead of turning off bed exit. " At the Graphical Room Station (GRS), click Menu " Click Manage Bed " On the Manage Bed screen, click the Safety Alerts ON / OFF slider button and the Delay button will pop up. Extend the silence period for the desired amount of time. Option 2: After working with a patient in the room, and prior to exiting the room, enable Patient Safety at the Graphical Room Station (GRS). " At the Graphical Room Station, click Menu " Click Manage Bed on the Manage Bed screen, toggle the Safety Alerts button to ON . For general questions regarding this communication, contact Baxter Technical Support at 1-800-445-3720, available twenty-four hours a day, seven days a week.