Sigma Spectrum Infusion Pump Problems Results In Urgent Warning Over Cleaning Practices

Cleaning problems with Sigma Spectrum infusion pumps may lead to serious and potentially life-threatening side effects, with more than a dozen serious injuries already reported, according to a new warning issued by the manufacturer and federal regulators.

An urgent device correction notice was published this week by the FDA and Baxter International Inc., highlighting risks which may result if medical providers deviate from the specified cleaning practices, which can impair the proper function of the infusion and cause a delay in treatment.

These failures to follow the recommended cleaning methods described in the Operator’s Manuals can lead to a buildup of residue or corrosion on the electrical pins. As a result, the user may get notices to check the battery, or it could cause the batteries not to charge or not to hold their charge. This can result in the pumps shutting down with no alarm or alert to the user, causing an interruption in medication delivery and treatment, which can lead to severe injury or death.

According to Baxter, deviations from the proper cleaning methods have resulted in at least 16 serious injuries, leading the FDA to categorize the warning as a Class I recall. This is the most serious recall classification and means the agency believes the problems with the infusion pumps could result in injury or death.

The recall affects the Baxter Signa Spectrum Infusion Pump System, with the V6 Platform (product codes 35700BAX and 35700ABB), the V8 Platform (product code 35700BAX2), or the Dose IQ Safety Software (product code 3570009). All serial numbers are affected.

More than 300,000 of the recalled infusion pumps were distributed in the United States, Canada, and the Caribbean.

Baxter urges customers to assess the rear case electrical pins and battery electrical contacts for residue buildup, corrosion and depressed pins to prevent issues. Baxter also recommends having backup devices readily available when infusing critical medications in case of a potential failure.

The infusion pumps should be connected to AC power when possible to prevent battery depletion.

This is not the first problem related to Sigma Spectrum Infusion Pumps. Baxter first issued a warning about the improper cleaning problem in a Safety Alert on April 1, 2020. Then the company issued an Urgent Device Correction notification on August 28, 2020 but continue to work a remedy for the ongoing problem.

Baxter plans to clarify the cleaning instructions and recommend a routine inspection to identify signs of residue buildup, corrosion, and depressed pins.

The company will issue a notification to inform customers of the availability of the update through Baxter’s Global Technical E-service center.