—#196091

Product

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part Number P00697901

FDA product code: KPN — Alarm, Conditioned Response Enuresis
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI/DI 00887761998865, all serial numbers

Why it was recalled

Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin pumps).

Root cause (FDA determination)

Device Design

Action the firm took

Baxter issued an Urgent Medical Device Correction on 09/30/2022. An updated letter was sent on 10/21/2022 to request that users temporarily stop using the WatchCare system. Hillrom, a Baxter company, has received reports of Radio Frequency (RF) interference with other devices near beds that are installed with WatchCare. Specifically, RF interference has been reported with telemetry devices, a bladder scanner, a fetal monitor/doppler, an infusion pump, and a personal use insulin pump. Other third-party medical devices may also be affected. While the system was developed to comply with the most-recent RF standards, it radiates RF that might affect other devices in the vicinity, including devices on both patients and staff members. Given the types of devices that may be affected on both patients and staff, serious harm or death may occur. No serious injuries or deaths reported. Actions to be taken: 1. 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 WatchCare to be disabled. Please contact Baxter at 1(800) 445- 3720 or technical.support@hillrom.com for assistance or discuss alternative actions while you wait for the WatchCare feature to be disabled. 2. Be aware that RF emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to, telemetry devices, bladder scanners, fetal monitor/dopplers, infusion pumps, and insulin pumps/blood glucose sensors). Please double-check all unexpected or atypical results and monitor infusions closely. 3. While Baxter continues to work to determine the etiology of this problem and the issue is resolved, use standard, non-RF-based, incontinence management pads. On April 06, 2023, an updated Medical Device Correction letter was sent to customers to infor

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2022-09-30
Posted by FDA: 2022-10-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.