Baxter warns of potential blockages in infusion pumps linked to 3 deaths

Errors in the setup or management of some of Baxter International’s infusion pumps could result in overlooked blockages in the pumps, potentially leading to serious injury or even death, the devicemaker warned in a recent urgent safety communication.

Baxter’s Spectrum infusion pumps are used to deliver medications, nutrients and other fluids directly to a patient’s body via IV, so any interruptions to that delivery could be life-threatening.

The safety notice was sent out (PDF) by Baxter in late December and published by the FDA this month. It notes that if the administration set for the Spectrum V8 or Spectrum IQ pump is improperly set up or upstream occlusion alarms issued by the pumps aren’t fully resolved, then future upstream occlusions may not sound an alarm at all. Users have also reported that the issue can cause a pump to deliver fluids at a rate different from the one programmed on the device.

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An upstream occlusion refers to a blockage that occurs before a fluid has reached the pump, commonly caused by improper connections from an IV bag to the pump, a kink or collapse in IV tubing, issues with tubing clamps and more.

If any of these issues occur, leaving the fluid unable to reach the infusion pump, and the pump, in turn, is unable to sound the proper alarm, it could result in either a reduction in or total stop to medication delivery, Baxter said.

According to the company, as of December, it had received more than 50 reports of serious injury and three reports of patient death in the last five years that it believes could be linked to issues with the upstream occlusion alarms. The safety notice covers more than 140,600 Spectrum V8 pumps and 175,000 Spectrum IQ systems—manufactured beginning in 2014 and 2017, respectively—that were distributed in the U.S., Canada, Puerto Rico and some Caribbean islands.

Healthcare facilities are still able to use both Spectrum infusion pumps, so long as they make sure to follow the devices’ onscreen instructions and additional information in their operating manuals. They should also take special care to ensure that any upstream occlusions are fully cleared before an infusion is restarted.

The FDA has not yet classified the safety event, though an eventual Class I label seems likely since it typically denotes a device malfunction with a high risk of serious patient injury or death.

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The Spectrum IQ system was at the center of a separate Class I event last year. Baxter launched the recall in July when it discovered an issue with its Dose IQ software, which healthcare providers can use to build a pre-programmed drug and dosing data.

In that case, a software flaw was found to be at risk of sending incorrect dosing information to the Spectrum IQ pumps, potentially leading to either under- or over-infusion of medication or a delay in drug delivery as the issue is sorted out. At the time, the FDA said it had received 15 complaints about the issue, with no reports of injury or death.