HQ Team
November 24, 2022: Baxter International has pulled the plug on its hospital bed systems in a recall termed by the FDA as “most serious” as the devices may cause death or injuries.
“The FDA has identified this as a Class I recall, the most serious recall. Use of these devices may cause serious injuries or death,” according to an email statement from the US health regulator.
Last year, Baxter acquired Hillrom for about $12.5 billion and recalled its WatchCare Incontinence Management System (IMS) from September 30, 2022.
It includes hospital beds and disposable incontinence pads designed to discreetly alert the caregiver of an event of involuntary urination or defecation.
RF interference
So far, 8,550 devices have been recalled in the US.
“Baxter Hillrom is recalling the WatchCare IMS after receiving reports that the radio frequency emissions (RF) from WatchCare devices may interfere with other medical devices,” according to the statement.
The devices include infusion and insulin pumps, blood glucose sensors, fetal monitors, telemetry devices and bladder scanners.
Other third-party medical devices may also be affected, according to the statement.
“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 has reported 96 complaints of interference. There have been no reports of serious injuries or deaths related to this issue.
The company has advised clinicians, biomedical engineers, and other end users to remove affected devices until the WatchCare functionality is disabled.
