The Oct. 21 announcement said that the WatchCare system was meant to comply with the most recent radio frequency standards. However, it appears to radiate RF that may affect other devices on caregivers and patients.
In all but two of the reports of problems, interference took place at a distance of less than 1 meter. Examples of potentially serious problems include:
- Insulin pumps overdosing insulin due to incorrect high glucose readings;
- “Phantom” incorrect fetal heart tone readings on fetal monitors;
- Problems with telemetry devices, bladder scanners and infusion injection pumps.
Baxter has no reports of injuries or death related to WatchCare’s RF.
The company is telling users and facilities to immediately locate all affected devices and stop the use of all WatchCare system accessories where possible until the disabling of RF-related functionality. Baxter continues to work to determine the problem’s cause. Until it resolves the issue, it says to use standard, non-RF-based incontinence management pads.
The Urgent Medical Device Correction covers Centrella Bed with WatchCare product number P7900B; WatchCare System for VersaCare Bed Rev. A-J product number P00697901; WatchCare System for VersaCare Bed Rev. K product number P00697902; WatchCare System for Progressa Bed product number P00697903; and WatchCare System for Centrella Bed product number P00697905.
More about Baxter’s WatchCare system
Baxter acquired the WatchCare system as part of its $12.5 billion acquisition of Hillrom in late 2021.
The device is a smart incontinence pad that integrates into healthcare facility beds. It’s meant to provide timely alerts to help reduce patient exposure to moisture. The Hillrom webpage for the system points to research saying that WatchCare reduced the time that skin was exposed to moisture from more than hours to 19 minutes in a 36-bed med-surg unit.