Sascha Schuermann
Baxter International (NYSE:BAX) has issued an urgent medical device correction for software installed on certain Spectrum infusion pumps over concerns that they may be emitting false alarms that could interfere with treatment.
The medical device maker said in a release on Friday that it is working with customers to revert the software on certain Spectrum V8 and Spectrum IQ pumps in the US and Puerto Rico due to concerns that the devices may indicate an upstream occlusion when none is present. The company said it has received three reports of serious injury that could be associated with the issue.
Baxter said that it was contacting customers about scheduling software reversions to correct the problem. The US Food and Drug Administration has also been alerted.
According to a note by BofA Securities on Monday, Baxter said the correction will not have a material impact on the company, nor will it prevent the company from continuing to sell the devices. The pumps do not need to be returned to Baxter as they can be fixed in the field, the analysts said.
BofA added that the correction will not impact the FDA’s review of Baxter’s Novum large volume pump.
On Thursday, Baxter released a Q2 earnings report that missed Street estimates on both the top and bottom lines, with shares of the medical device maker closing 7% lower following the news. The shares rebounded a bit on Friday, but were trading 3% lower midday Monday.
Baxter is in the midst of spinning out its kidney care unit as a separately traded company to be called Vantive. Last week, Baxter said that it expects to complete the spinout by July 2024.
More on Baxter:
Baxter International Inc. (BAX) Q2 2023 Earnings Call Transcript
Baxter Non-GAAP EPS of $0.55 misses by $0.06, revenue of $3.71B misses by $80M
Baxter names proposed kidney care spinoff ‘Vantive’
Why 2023 is turning into the year of the healthcare spinoff
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