According to MassDevice, wo recalls have been issued by the U.S. Food and Drug Administration (FDA) for CareFusion’s Alaris Pumps. One is for CareFusion for alarm issues and the other is for Elite Biomedical Solutions for a flaw in a replacement frame membrane for drug pumps.
The recalls have been labeled by the FDA as Class 1, which means, “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
108 reports of errors were reported to CareFusion in which a visual and audible alarm caused the Alaris pump to stop supplying infusions to the patient.
The FDA reports that even after this error is cleared, the pump will not respond until it is completely disconnected and reconnected to the computer.
CareFusion has received no reports of death or serious injury.
This recall also involves an Alaris pump, specifically a replacement piece, manufactured by Elite Biomedical Solutions.
The replacement piece is a frame membrane that is designed to prevent fluids from leaking into internal components.
Elite Biomedical Solutions discovered that the replacement frame membrane interfered with infusions, causing the patient to receive either to many or not enough infusions. This posed a great risk of injury or death.
CareFusion has stated that they will repair the recalled units within 60 days and advise that customers use alternative units until that time. They started reaching out to customers about the issue on June 20th, 2015. Elite Biomedical Solutions also urges customers to discontinue use and quarantine unused products.