Alaris infusion interoperability backlog can load outdated pump orders

Incident

Alaris infusion interoperability backlog can load outdated pump orders

18 February 2025United StatesFell to tier 1: assisted operationDevices Connectivity & data Human handoff

A Class I software correction found that backlogged EHR-to-pump automated programming requests could load stale rate, dose or volume parameters.

Sources checked when written 26 September 2026

TierClinicians were told to verify every pump parameter against the order before starting: automation demoted to advice. How tiers are assigned.

What happened

FDA announced that with BD Alaris Systems Manager (v12.5.2 and earlier) and Care Coordination Engine Infusion Adapter (v1.7.2), delayed responses could cause automated programming requests to back up, so an outdated request could later load on the pump with different rate, dose or volume parameters; if accepted, the patient could receive the wrong dose. It was classified as the most serious recall type. No injuries or deaths were reported. Clinicians were told to verify all parameters before starting and to update the adapter software. The same pump platform had a Class I software recall in 2020 for five issues including a low-battery alarm failure.^[1,2]

Documented harm

None reported (FDA).

What it teaches

Integration queues turn latency into stale commands; a late order is a wrong order.
Auto-programming does not remove the need for a human check at the pump; it moves the check.
Watch interface engine queue depth as a patient safety signal, not an IT metric.

Sources

Infusion Pump Software Correction: BD Issues Correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software Due to Risk for Outdated Automated Programming Requests to Load. U.S. Food and Drug Administration, 18 February 2025. Primary Official report · link checked 2026-09-26
BD Provides Update on Feb. 4, 2020 Voluntary Recall of the BD Alaris System PC Units and Modules. U.S. Food and Drug Administration (company announcement), 9 March 2020. Primary Official report · link checked 2026-09-26

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