Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps are used to give fluids to patients in precisely controlled amounts. They deliver blood or blood products, lipids, drugs, antibiotics, enteral feedings and other therapeutic fluids through infusion tubing into a patient's vein or through other cleared routes of administration. Syringe pumps are primarily used in the neonatal and pediatric populations or in operating rooms and intensive care units for the adult population.

Smiths Medical is recalling Medfusion 3500 and 4000 Syringe Infusion Pumps for eight software malfunctions that affect different serial numbers and software versions. These 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 as follows:(1) False alarm for Primary Audible Alarm (PAA) system failure(2) Unanticipated Depleted Battery Alarms(3) Abnormal circuit board behavior, which may cause internal clock system failure(4) Intermittent Volume Over Time (IVOT) delivery mode where the infusion continues after system failure(5) Unanticipated clearance of Program Volume Delivered (PVD)(6) False alarm for Rate Below Recommended Minimum for Syringe Size(7) Incorrect bolus or loading dose time display(8) Network configuration may affect pump communications.

Smiths Medical states there have been a total of 7 serious injuries and one death reported related to these issues. The Customer Notification identifies the injuries and/or deaths associated with each software issue.

Smiths Medical sent an Urgent Medical Device Correction letter to customers on April 19, 2022. The letter included an overview of each issue, the affected pump models, the potential risk to patients, and recommended actions for clinicians and for biomedical engineers for several issues. Smiths provided the following additional instructions to customers:

Customers can contact Smiths Medical with questions or concerns.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

07/20/2022