Baxter International has issued a Class I recall—the most serious type of recall—for its its Spectrum V8 and Spectrum IQ infusion pumps. This recall arrives on the heels of a recent urgent safety communication regarding the upstream occlusion alarms of the devices.
The U.S. FDA says use of the baxter infusion pump devices may cause serious injuries or death.
The recall pertains to the device maker’s Spectrum V8 and Spectrum IQ infusion pumps, which are used in clinical settings to automatically deliver medications, blood, nutrients and other fluids directly to a patient’s body through an intravenous line.
As detailed in the original safety notice (PDF), which was sent to healthcare providers at the end of December 2021, Baxter identified a technical issue with the devices that may keep them from emitting an alarm for repeated upstream occlusions—in which the system becomes blocked between the IV bag and the pump.
The recall encompasses more than 277,000 devices distributed in the U.S. between early 2015 and this year, according to the FDA.
The recalled Baxter infusion pump products are specified as follows:
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Product code: 35700BAX2
- Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9)
- Product Code: 3570009
The FDA says Baxter has received 51 reports of serious injuries and three reports of patient deaths over five years, potentially associated with this issue.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Read the full article at Fierce Biotech.