FDA Reports Class I Recall for Baxter WatchCare Incontinence Management System
Last week, the FDA announced a Class I recall, the most serious type of recall, for Baxter International’s Incontinence Management System due to risk of radiofrequency (RF) interference with nearby medical equipment. The WatchCare Incontinence Management System (IMS) includes specific Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. The system is designed to discreetly alert a caregiver of an incontinence event and is typically used in critical care and medical/surgical settings, as well as in other clinical areas. Those who may be most affected by the recall are people receiving care in hospital beds with the WatchCare IMS accessory installed and healthcare personnel who care for patients in the above situation.
Product models affect include:
- 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 for affected devices were from between Aug. 1, 2018, to Sept. 1, 2022.
The company is recalling the system after receiving reports that the RF from WatchCare devices may interfere with other medical devices, including equipment critical to the health and wellbeing of patients. Affected devices include infusion pumps, insulin pumps, blood glucose sensors, fetal monitors/dopplers, telemetry devices, and bladder scanners. The FDA’s recall notice also stated that other third-party medical devices may also be affected.
Baxter reported that the RF interference from the system may cause erroneous readings or malfunctions of these other devices on both patients and staff, which could lead to inappropriate medical treatment or no treatment when needed. If the RF emissions affect a medically necessary device like a blood glucose sensor or fetal monitor, the issue could lead to serious injury or death, leading to why the administration classified the recall as Class I.
Baxter initially sent customers an Urgent Medical Device Correction letter on Sept. 30 and an updated letter on Oct. 21, which recommended clinicians, biomedical engineers, and other end users to immediately locate all affected devices and remove them from clinical care areas where possible until the WatchCare functionality is disabled. The company reported 96 complaints of interference and, to date, all interference cases but two occurred at distances less than one meter. There have been no reports of serious injuries or deaths related to the issue.