FDA MedWatch - Sigma Spectrum Infusion Pumps (V6, V8 and IQ) by Baxter: Urgent Device Correction to Reinforce Safety Information Regarding Cleaning Practices

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Sigma Spectrum Infusion Pumps (V6, V8 and IQ) by Baxter: Urgent Device Correction to Reinforce Safety Information Regarding Cleaning Practices AUDIENCE: Health Professional, Risk Manager ISSUE: Baxter International Inc. issued an Urgent Device Correction to reinforce safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean. Deviations from the specified cleaning methods may impair infusion pump functionality and performance. Deviations from the cleaning methods described in product-specific Operator's Manuals may lead to residue buildup or corrosion of the electrical pins (e.g. depressed pins) on the infusion pump rear case and battery electrical contacts. This could result in notifications that the user should check the battery, or that batteries are not charging or holding their charge. If a device has residue buildup or corrosion, and is running solely on battery power, the pump may shut down without alarming or alerting the user. An undetected or abrupt discontinuation in medication delivery may lead to a delay or interruption of intended treatment. Depending on various factors, including the medication being infused, the volume and rate of the infusion, the route of administration, and patient status and comorbidities, this could result in serious adverse health consequences or death. To date, Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion. For product description, product codes and serial numbers, click the blue button "Read More" below. BACKGROUND: Sigma Spectrum Infusion Pumps are used for the controlled administration of fluids. Baxter previously communicated this information to customers directly in a Safety Alert on April 1, 2020 and subsequently via an Urgent Device Correction notification on August 28, 2020. RECOMMENDATION: Baxter is instructing customers to: Adhere to the cleaning instructions provided in the Operator's Manuals Assess the rear case electrical pins and battery electrical contacts for residue buildup or corrosion and depressed pins.  Have backup devices readily available when infusing critical medications. The infusion pumps should be connected to AC power when possible to prevent battery depletion. Baxter will be clarifying the Instructions for Use (IFU) to recommend a routine inspection to identify signs of residue buildup, corrosion and depressed pins.  Health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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