Baxter International, Inc. issued an Urgent Safety Communication to reiterate critical information related to upstream occlusion alarms for its Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration setup and/or incomplete resolution of upstream occlusion alarms could lead to reduced delivery or non-delivery of medication—and thus could occur without the pump alarm alerting the user. “As described in the Urgent Safety Communication notification, after an upstream occlusion alarm, it is imperative to fully resolve any upstream occlusion before restarting the pump. Failure to do so may cause the pump not to re-alarm as expected, which can lead to interruption in therapy and/or under-infusion. The potential harm to the patient depends on several factors such as length of therapy delay, medication being infused, volume and rate of infusion, and the patient’s underlying status and comorbidities,” Baxter stated in its company announcement, which was posted on the FDA website.
Thus far, the company has received 51 reports of serious injury and three reports of patient death over five years.
The Spectrum V8 and Spectrum IQ have been distributed to the United States, Puerto Rico, Canada and certain Caribbean Islands. Customers have been told that they can continue to use the infusion pumps by following on-screen instructions and using the Operator’s Manual, with further details included in the Baxter announcement.