FDA MedWatch - Medfusion 3500 and 4000 Syringe Pumps by Smiths Medical: Class I Recall - Due to Risk of Medication Delivery Error

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Medfusion 3500 and 4000 Syringe Pumps by Smiths Medical: Class I Recall - Due to Risk of Medication Delivery Error AUDIENCE: Patient, Health Professional, Risk Manager, Pediatrics ISSUE: Smiths Medical is recalling specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over-delivery or under-delivery of fluids or medication. Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted. Use of the affected syringe pumps may cause serious adverse health consequences including death. There have been four complaints regarding this device issue including one serious injury. There have been no deaths. For more information about this recall, models and firmware versions, click on the red button "Read Recall" below. BACKGROUND: The Smiths Medical Medfusion Syringe Pump delivers blood, blood products, prescribed drugs, and other fluids into a patient's body in a controlled manner. Syringe pumps are primarily used in the neonatal and pediatric populations or in operating rooms and intensive care units for the adult population. RECOMMENDATIONS: On June 26, 2020, Smiths Medical sent an Urgent Medical Device Recall notice to all affected customers and provided the following instructions: Locate all Medfusion 3500 and 4000 Syringe Pumps in possession and verify the firmware version to determine if the pump(s) is impacted by this notice. Ensure all personnel who may utilize the pump are aware of this recall. For any reason, when a bolus or loading dose delivery is interrupted, cancel the bolus or loading dose and begin a new infusion to avoid potential inappropriate delivery. Complete and return the response form attached to the notice and email it to Smiths Medical. Health professionals and patients 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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