Class 1 Device Recall The WatchCare Incontinence Management System

• Date Initiated by Firm: September 30, 2022
• Date Posted: October 31, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0142-2023
• Recall Event ID: 90865
• Product Classification: Alarm, conditioned response enuresis - Product Code KPN
• Product: Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
• Code Information: UDI/DI 887761984998, all serial numbers
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: 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).
• FDA Determined Cause: Device Design
• Action: 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
• Quantity in Commerce: 814 units
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.