Baxter—SIGMA SPECTRUM Infusion Pumps with Master Drug Library: May Incorrectly Issue Upstream Occlusion Alarm and/or Air-in-Line Alarm

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In a June 10, 2013, Urgent Device Correction letter submitted by an ECRI Institute member hospital, Baxter states that the occlusion/air sensor of the pumps below may incorrectly issue an upstream occlusion/air-in-line alarm when no visible source of occlusion or air is present. Baxter also states that it has received reports of this problem occurring. Baxter further states that the alarm will interrupt the therapy and issue an audible and visual alert until resolved by the clinician and that any unattended interruption of therapy to the critical patient population may require additional medical intervention, potentially resulting in patient harm or life-threatening conditions. The manufacturer has not confirmed the...