Hospira—Symbiq 1- and 2-Channel Infusion Pumps: May Emit False Proximal Alarms that Cannot Be Cleared
February 13, 2013 | Risk Management News
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In a February 4, 2013, Urgent Device Field Correction letter submitted by Hospira, the firm states that it has received reports of the pumps below emitting false proximal occlusion alarms that cannot be cleared by the clinician. Hospira also states that these alarms may be related to the interaction between the proximal occlusion sensing subsystem of the pump and the administration set. When a proximal occlusion is detected, a high-urgency visual and audible warning alarm is initiated and the infusion is stopped. A proximal occlusion alarm that cannot be cleared may result in a delay or interruption in therapy, potentially requiring the clinician to reset the alarm multiple times or replace the pump. The severity of the delay in therapy is dependent upon the underlying condition of the patient. In the worst case scenario, a delay or interruption...