Devices

Baxter Safety Alert on Spectrum Infusion Pumps

Baxter International has issued an urgent safety communication to highlight important information on the device’s upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. “Incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication, in some cases without alerting the user via pump alarm,” the company alert says. Baxter previously communicated related safety information in December.

According to the company, customers notified Baxter that the pump was not delivering medication at the programmed rate displayed on the screen, and in some cases was not alarming for upstream occlusions. It says that “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.”

To date, Baxter says it has received 51 serious injury reports and three patient death reports over five years that “may have resulted from incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms.”

Baxter says the pumps can continue to be used by following on-screen instructions and referencing the operator’s manual for infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section. Additionally, the alert offers recommendations on how to prevent occlusions.

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