On July 20, 2022, the U.S. Food and Drug Administration (FDA) reported 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.
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:
- False alarm for primary audible alarm system failure
- Unanticipated depleted battery alarms
- Abnormal circuit board behavior
- Intermittent volume over time delivery mode where the infusion continues after system failure
- Unanticipated clearance of program volume delivered
- False alarm for rate below recommended minimum for syringe size
- Incorrect bolus or loading dose time display
- Network configuration may affect pump communications
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:
- Locate all affected pumps in their possession and ensure all users or potential users of these devices are immediately made aware of the recall and proposed mitigations.
- Ensure an additional pump is available in case of interruption if they are using the Medfusion pump to deliver life-sustaining medications. If the actions for users for each issue are inadequate to resume the infusion, use a different pump to continue the infusion.
- Complete and return a response form to firstname.lastname@example.org.
Consumers can contact Global Complaint Management at email@example.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 they experienced using the devices to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.