Medfusion Syringe Pump Recall Issued Over Software Errors

Smiths Medical is recalling more than 85,000 Medfusion Syringe Pumps due to software problems that can cause medication errors, which have already been linked to at least one patient injury.

The U.S. Food and Drug Administration (FDA) announced the Medfusion 3500 Syringe Pump recall on March 5, 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 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.

Smiths Medical previously announced a recall for these products in December 2023, after discovering problems with how the syringe pumps were delivering insulin and other drugs. The pumps were found to have a software defect that causes them to administer to too much or too little of vital medications, blood, or fluids, which could lead to serious injury or death.

Medfusion Syringe Pumps Recall

The recall affects an estimated 85,961 units of the Model 3500 Medfusion syringe pumps, which were distributed between August 9, 2002 and August 15, 2023.

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 issues could cause the pump to fail if undetected, resulting in a delay or interruption of the delivery of life-saving drugs.

The manufacturer indicates that 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 is 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. Last month, similar problems led to a Medfusion 4000 Syringe Pump recall affecting more than 50,000 devices.

For this latest recall, an Urgent Medical Device Correction letter was sent to customers on December 19, asking them to locate all of the affected pumps and ensure that users are immediately aware of the potential problems and what to do if they occur. It also urged customers to ensure that 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.

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.