Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment | FDA

2022-12-07 16:27:27 By : Ms. Tracy Yu

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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 (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. 

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:

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. 

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: 

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 technical.support@hillrom.com.

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.