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WatchCare recallZ-0143-2023 · Baxter Healthcare Corporation · initiated Sep 30, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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).

FDA root cause category: Device Design

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-0143-2023
Status
Open, Classified
Initiated by the company
Sep 30, 2022
Posted by the FDA
Oct 31, 2022
Recalling firm
Baxter Healthcare Corporation
Quantity
1137 units
Product code
KPN
Distribution
US

Product description

Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.

Code information (models, lots, serial numbers)

UDI/DI 00887761998889, all serial numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90865).

Sources and updates

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