Baxter (NYSE:BAX) announced today that it has issued an urgent safety communication regarding upstream occlusion alarms for certain infusion pumps.
Deerfield, Illinois–based Baxter warned that incorrect administration set setup and/or the incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication. The problem might occur without the users receiving alerts via pump alarm in some cases. The issue involves all Spectrum V8 and Spectrum IQ infusion pumps.
Baxter received 51 reports of serious injury and three reports of patient death over five years that may have resulted from incorrect administration set setup or incomplete resolution of upstream occlusion alarms.
The information was originally sent to customers in an urgent safety communication notification on Dec. 29, 2021, according to a news release.
Customers informed 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. After an upstream occlusion alarm, the occlusion must be fully resolved before restarting the pump. Failure to do so potentially results in the pump not re-alarming as expected, which can interrupt therapy and/or cause under-infusion.
Potential harm varies based on factors including length of therapy delay, medication being infused, volume and rate of infusion and the patient’s underlying status and comorbidities.
Customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions and referencing the operator’s manual-external link disclaimer for infusion setup instructions, according to Baxter. Users must completely spike the IV container, remove the blue slide clamp, disengage the blue slide clamp from the IV tubing, make sure that the IV tubing is clear of kinks or collapsed sections, ensure the roller clamp is released prior to infusion start and ensure that rigid and semirigid containers are properly vented, all in order to help prevent upstream occlusions.
Baxter said that after the infusion begins, users should verify that drips are flowing in the drip chamber. If an upstream occlusion remains after the RUN/STOP key is pressed, the pump may appear to be infusing normally but could be infusing below the programmed rate or not at all. If a clinician suspects infusion was resumed without clearing an occlusion, they should stop the infusion with the RUN/STOP key, clear the occlusion and restart the infusion.
Baxter distributes Spectrum V8 and Spectrum IQ infusion pumps in the U.S., Puerto Rico, Canada and certain Caribbean islands.