Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery

July 21, 2022

On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-certain-medfusion-3500-and-4000-syringe-infusion-pumps-software-issues-may?utm_medium=email&utm_source=govdelivery) Smiths Medical’s recall of its Medfusion 3500 and 4000 syringe infusion pumps because of software malfunctions. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Malfunctions That Can Affect Infusion Delivery

The recall affects 118,055 devices of the Medfusion 3500 and 4000 syringe infusion pumps. The parts were distributed from October 2004–February 17, 2022. For a list of models, product codes, and software versions included in the recall, see the recall database entries:

Smiths Medical has reported one death and seven serious injuries related to the software malfunctions, which can result in under- or overinfusion or delays in delivery of critical medications, resulting in serious patient harm or death. 

The following software malfunctions may occur:

Smiths Medical notified consumers of the software problems via a letter in April 2022 and provided an overview of each issue, affected pump models, potential risk to patients, and recommended actions for clinicians and biomedical engineers. The company said it will address the issues through upcoming software releases and will update affected pumps that are within their service life. Smiths Medical will contact consumers to implement the software updates when they are available; until then, the company advised consumers to:

Consumers can contact Global Complaint Management at globalcomplaints@smiths-medical.com (mailto:globalcomplaints@smiths-medical.com) or 866-216-8806 to report adverse events or product complaints. For additional technical assistance, consumers can call 800-258-5361.

Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using the devices to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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