Drugs

Baxter Class 1 Recall of Sigma Infusion Pumps

FDA has classified as Class 1 a recall of certain Sigma Spectrum infusion pumps made by Baxter, warning that continued use of the affected devices could result in serious injury or death. The recall involves removing specific Sigma Spectrum Infusion System platforms from clinical use after Baxter determined that some pumps may be running incorrect software. According to an FDA notice, software designed for the Spectrum V8 platform may have been installed on Spectrum V6 pumps, and vice versa, creating a risk of inaccurate drug delivery.

Affected products include Sigma Spectrum infusion pumps operating on the V6 and V8 platforms, identified by product codes 35700BAX and 35700BAX2, respectively. The FDA said the mismatch between pump hardware and software could lead to overinfusion or underinfusion, particularly during prolonged infusions.

FDA said the risk extends beyond dosing accuracy. The V6 and V8 pumps differ in clinical workflow and user interface design, meaning clinicians trained on one platform could be confused if the device is running the other platform’s software. That confusion could result in delays, misprogramming, or interruptions in therapy.

Potential consequences include drug toxicity, overdose, fluid overload, electrolyte imbalances, or subtherapeutic dosing that could render treatments ineffective, according to the agency.

Sigma Spectrum infusion pumps are widely used in hospitals to deliver intravenous fluids, blood, blood products, and medications under the supervision of trained healthcare professionals.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome