Medfusion Syringe Pump Recall Issued After Software Error Linked to Injury Risk

Similar software problems resulted in an earlier Medfusion pump recall in 2022, affecting about twice as many units that may pose a risk of serious and life-threatening injuries.

Smiths Medical is recalling approximately 50,743 Medfusion Syringe Pumps, due to software problems that can cause errors in the delivery of medication, which has already been linked to at least one patient injury.

The U.S. Food and Drug Administration (FDA) announced the Medfusion 4000 Syringe Pump recall on February 14, indicating that the software defect may cause the pumps to malfunction during administration, resulting in either excessive or insufficient delivery of medication, blood, or fluids. The FDA has given the recall a Class I designation, meaning the agency believes the problem could lead to severe patient injuries or deaths.

The Medfusion syringe pumps are used to administer fluids, medications, and other substances in precise quantities. They are commonly utilized in critical care, anesthesia, neonatal, and pediatric settings.

Medfusion Syringe Pump Recall

According to the recall notice, the affected Medfusion syringe pumps have problems linked to earlier software versions, that can affect the alarm system, the pump, and the control screen. These could cause the pimp to fail if undetected, resulting in a delay or interruption of the delivery of life-saving drugs.

Smiths Medical sent an Urgent Medical Device Correction letter to customers on December 19, asking them to locate all of the affected pumps and make sure users are immediately aware of the potential problems, and what to do if they should occur. It also urged customers to make sure their Medfusion pumps have the most recent software installed, and to complete the response form provided. The completed forms should be returned to smithmedical6114@sedgwick.com within ten days of receiving the letter..

The recall affects Model 4000 Medfusion syringe pumps, distributed between November 16, 2010 and July 28, 2023. The recall affects an estimated 50,743 units.

The manufacturer indicates there are ten software malfunctions affecting various serial numbers and software versions. These malfunctions have the potential to cause serious harm or death to patients due to under or over-infusion, as well as delays in the delivery of critical medications to patients. A complete list of the affected software versions are included in the recall notice.

Smiths Medical initially reported similar problems in April 2022, resulting in a recall of more than 118,000 Medfusion Syringe Infusion Pumps  in July of that year.

Customers with further questions regarding this recall can contact Smiths Medical at 1-866-216-8806. Side effects or adverse events should also be reported to the FDA’s MedWatch Adverse Event Reporting Program.