CareFusion—Model 8015 Alaris Infusion Pump System PC Units: Software Anomaly May Result in Infusion Outside Established Guardrails Limits

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In a May 13, 2015, Urgent Medical Device Recall Notification letter submitted by an ECRI Institute member hospital, CareFusion states that if a clinician programs an infusion outside the hospital established limits, uses a specific sequence of programming steps using the cancel key, and then presses the smart key on the infusion parameters verification screen, the systems below may start to infuse the medication outside Guardrails limits established by the hospital without providing a Guardrails popup notification on the PC unit display. This problem may result in injury depending on the patient's condition, infusion parameters programmed outside of hospital-defined limits, and type of drug being infused. FDA's Center for Devices and Radiological Health (CDRH) states that the manufacturer updated the software for the above systems in relation to the cancel functionality that is used during atypical infusion programming to cancel user-inputted values. FDA's CDRH also states that the manufacturer initiated a software update by Urgent Medical Device Recall Notification letter dated May 13, 2015. The manufacturer has not confirmed the information provided in the source material.

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