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Baxter infusion pumps medical device correction overview:
- Who: Baxter issued an urgent medical device correction for Spectrum V8 and Spectrum IQ infusion pumps.
- Why: The company issued the correction after an increase in reported false upstream occlusion alarms following software upgrades.
- Where: The Baxter infusion pumps medical device correction is active in the United States and Puerto Rico.
Baxter issued an urgent medical device correction for Spectrum V8 and Spectrum IQ infusion pumps after a software upgrade led to an increase in reported false alarms. The issue has so far led to three reports of serious injury, the company says.
The U.S. Food & Drug Administration website published the correction July 28. It applies to the SIGMA Spectrum Infusion System (V8 Platform) with product code 35700BAX2 and software version v8.01.01 and Spectrum IQ Infusion System with Dose IQ Safety Software with product code 3570009 and software version v9.02.01 distributed in the United States and Puerto Rico.
According to the notice, the issue started after Baxter upgraded the pumps to software versions v8.01.01 and v9.02.01. The upgraded software may cause an alarm for an upstream occlusion when there is no actual upstream occlusion present, the Baxter infusion pumps notice states.
“This false alarm may lead to an interruption or delay of therapy,” the notice says. “An interruption or delay of therapy may cause serious adverse health consequences in patients who are receiving life-sustaining medications.”
So far, Baxter received three reports of serious injury potentially associated with the issue, it says. The company is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes end in class action lawsuits.
Baxter contacting customers to revert software update, medical device correction states
Baxter representatives are contacting all affected customers to schedule the software reversion, the notice states.
Until the reversion is completed, false upstream occlusion alarms can occur on impacted pumps at a higher rate, according to the medical device correction.
Customers can continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions or referencing the preparing the pump and IV sets and programming the pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the operator’s manual, the Baxter infusion pumps notice states.
“If a customer is unable to resolve an upstream occlusion alarm, they should unload and reload the set,” the medical device notice states.
In 2014, Baxter recalled its DIANEAL PD-2 (peritonea dialysis solution) due to the concern of mold contamination and injury reports.
Are you affected by this infusion pump notice? Let us know in the comments.
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