Baxter hospital bed systems recall classified as most serious by USFDA
The device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors, and bladder scanners, among others.
New Delhi: The U.S. health regulator on Wednesday classified the recall of hospital bed systems by Baxter International Inc, as the most serious type, on concerns it could lead to life-threatening injuries or death.
Baxter initiated the recall of its WatchCare Incontinence Management System, which is used to discreetly alert an incontinent patient's caregiver of involuntary urination or defecation, by sending a correction letter to its customers in late September.
In the letter, Baxter warned users about the potential for WatchCare's radio frequencies to interfere with other medical devices. The correction letter was updated last month to include actions healthcare practitioners could undertake in case they encountered any malfunction or interference.
The device was found to interfere with other nearby critical devices such as infusion pumps, insulin pumps, blood glucose sensors, and bladder scanners, among others. The Food and Drug Administration said the interference from WatchCare may lead to erroneous reading or malfunctions on other devices, causing inappropriate medical treatment for patients.
Baxter, which makes smart hospital beds, recalled 8,550 WatchCare devices distributed between Aug. 1, 2018, and Sept. 1, 2022.
The recall was based on 96 reported complaints of interference with no reports of injuries or death related to the product, the FDA said.
Baxter said it has sought the location and removal of the device from clinical care areas, where possible.
Many of the recalled WatchCare devices were manufactured by Hillrom, which was acquired by Baxter in late 2021.
Read also: Baxter Pharma India sets up global Pharmaceuticals RnD Centre in Ahmedabad
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.