Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment
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.
- Product Name: WatchCare Incontinence Management System (IMS)
- Product Models:
- P7900B Centrella Bed with WatchCare
- P00697901: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. A-J
- P00697902: Hospital Bed Accessory, WatchCare System for VersaCare Bed Rev. K
- P00697903: Hospital Bed Accessory, WatchCare System for Progressa Bed
- P00697905: Hospital Bed Accessory WatchCare System for Centrella Bed
- Distribution Dates: August 1, 2018 to September 1, 2022
- Devices Recalled in the U.S.: 8,550
- Date Initiated by Firm: September 30, 2022
The WatchCare Incontinence Management System (IMS) 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.
Reason for Recall
Baxter Hillrom is recalling the WatchCare IMS after receiving reports that the radiofrequency emissions (RF) from WatchCare devices may interfere with other medical devices, including equipment that is critical to the health and wellbeing of patients, such as:
- 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 1 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.
Who May be Affected
- People who receive care in hospital beds with the WatchCare IMS accessory installed.
- Health care personnel who care for patients in hospital beds with the WatchCare IMS accessory installed.
What to Do
On September 30, 2022, Baxter Hillrom sent customers an Urgent Medical Device Correction letter. An updated letter was sent on October 21, 2022, which recommended the following actions for clinicians, biomedical engineers, and other end users:
- Immediately locate all affected devices and remove them from clinical care areas (where possible) until the WatchCare functionality is disabled. Affected devices are those Centrella, Progressa and Versacare beds which have WatchCare functionality. Baxter will contact you to arrange for the WatchCare to be disabled, and their technical support can assist and provide alternative actions until the features are disabled.
- Be aware that RF emissions from functioning WatchCare devices may impact other devices including, but not limited to, telemetry devices, bladder scanners, fetal monitors/dopplers, infusion pumps, insulin pumps, and blood glucose sensors.
- Double check all unexpected or atypical results and monitor infusions closely.
- Use standard, non-RF based incontinence management pads until the issue is resolved.
- Share this notice with all potential users and staff in your organization.
- Complete the response form (attached to the letter) and return to Hillrom-FA2022043@sedgwick.com within two weeks to acknowledge receipt and understanding.
- Report any irregular activity or product complaints connected to the use of the WatchCare System to Baxter at 1-800-445-3720.
- For distributors: Share with end users, complete the response form and return to Hillrom-FA2022043@sedgwick.com within two weeks. Electronic copies of the notification and response form can also be provided by reaching out to this address.
Baxter will contact all impacted customers to arrange for WatchCare functionality to be switched off.
The company will also provide a follow-up when more information is available.
Customers with technical questions about this recall should contact Baxter Hillrom Technical Support at 1-800-445-3720 or email@example.com.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.