Medfusion Syringe Infusion Pump Recall Issued After Injuries, Patient Death

Smiths Medical is recalling more than 118,000 Medfusion Syringe Infusion Pumps, warning that the device software can malfunction, resulting in medication errors or other problems that may have already caused at least one death.

The FDA announced the Medfusion 3500 and 4000 Syringe Infusion Pump recall on July 20, due to a risk that the software defect may affect the devices’ ability to deliver an accurate amount of drugs to the patient’s body when needed.

The infusion pumps are used to deliver fluids, drugs and other items in controlled amounts. However, the softeware may cause the pump to malfunction during delivery, resulting in over- or -under delivery of medication, blood or fluids. The recalled syringe pumps are primarily used in the neonatal and pediatric populations, or in operating rooms and intensive care units for the adult population.

At least seven serious injuries and one death have been reported in connection with the recalled Medfusion Syringe Infusion Pumps so far.

Smiths Medical first announced the problems in a notice on April 19, 2022, which the FDA has now categorized as a Class I medical device recall, suggesting that continued use of the device may pose a risk of severe injury or death.

The manufacturer indicates there are eight software malfunctions which affect different serial numbers and software versions. The malfunctions may cause serious harm or death to patients from under- or over-infusion, or delays in the delivery of critical medications to patients.

The eight software issues are:

• False alarm for Primary Audible Alarm (PAA) system failure
• Unanticipated Depleted Battery Alarms
• Abnormal circuit board behavior, which may cause internal clock system failure
• Intermittent Volume Over Time (IVOT) delivery mode where the infusion continues after system failure
• Unanticipated clearance of Program Volume Delivered (PVD)
• False alarm for Rate Below Recommended Minimum for Syringe Size
• Incorrect bolus or loading dose time display
• Network configuration may affect pump communications

The devices were distributed October 2004 to February 17, 2022.

Smiths Medical sent an Urgent Medical Device Correction letter to customers on April 19, 2022, recommending actions for doctors and biomedical engineers for several of the software issues.

The company indicates it plans to address the issues with upcoming software releases and will update affected pumps which are within their service life at no charge. The company says it will contact customers to schedule the software updates when they are ready.

In the meantime, customers can contact Smiths Medical with questions about the recall at 1-866-216-8806.

Side effects or adverse events should also be reported to the FDA’s MedWatch Adverse Event Reporting Program.