Baxter Hillrom is recalling the WatchCare Incontinence Management System (IMS) after receiving reports that the radio frequency (RF) emissions from WatchCare devices may interfere with other medical devices, including equipment that is critical to the health and wellbeing of patients.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The WatchCare Incontinence Management System includes specific Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. It is designed to discreetly alert the caregiver of an incontinence event. The system is usually used in critical care and medical/surgical settings as well as in other clinical areas.
The device distribution dates were between Aug. 1, 2018 to Sept. 1, 2022, and 8,550 devices are being recalled.
Equipment affected by the interferences of the IMS include:
- Infusion pumps
- Insulin pumps
- Blood glucose sensors
- Fetal monitors / dopplers
- Telemetry devices
- Bladder scanners
Other third-party medical devices may also be affected. The RF interference from WatchCare may cause erroneous readings or malfunctions of these other devices on both patients and staff, which could lead to inappropriate medical treatments or lack of treatment. If WatchCare RF emissions affect a medically necessary device such as a blood glucose sensor, insulin pump, fetal monitor, or general infusion pump, among others, this issue could lead to serious injury or death.
Baxter reported 96 complaints of interference. To date, interferences in all cases but two occurred at distances less than one meter. There is insufficient data about distance on the remaining two reported interferences. There have been no reports of serious injuries or deaths related to this issue.
Baxter says it will contact all impacted customers to arrange for WatchCare functionality to be switched off and will also provide a follow-up when more information is available.