Iv infusion pump

Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Infusion Pumps Due to Software Malfunctions

If you or a loved one suffered an injury during surgery or a hospital stay due to improper or delayed dosing from a malfunctioning syringe pump, you may have a case against the manufacturer.

In April 2022, Smiths Medical recalled Medfusion 3500 and 4000 Syringe Infusion Pumps due to software malfunctions that can impact infusion delivery. 118,055 devices distributed from October 2004 through February 17, 2022, were recalled.

The U.S. Food and Drug Administration (FDA) reported the recall as Class 1 in July 2022. The FDA classified the recall as Class 1 because using the products could cause serious injuries or death to users.

Medfusion 3500 and 4000 Syringe Infusion Pumps are used to deliver vital fluids such as blood or blood products, lipids, drugs, antibiotics, enteral feedings, and other therapeutic fluids to patients through their veins. The syringe pumps are normally used in neonatal and pediatric populations. For adults, the syringe pumps are used in operating rooms and intensive care units (ICUs).

Smiths Medical reported one death and 7 serious injuries related to the software malfunctions in the devices. The injuries and death were caused by under- or over-infusion or delays in the delivery of critical medications. In April 2022, Smiths Medical sent an Urgent Medical Device Correction letter to customers alerting them of the software issues.

Smiths Medical listed 8 software malfunctions that can impact the Medfusion syringe infusion pumps:

  1. False alarm for Primary Audible Alarm (PAA) system failure

  2. Unanticipated depleted battery alarms

  3. Abnormal circuit board behavior may cause the system’s internal clock to fail

  4. Intermittent Volume Over Time (IVOT) delivery mode where the infusion continues after a system failure

  5. Unanticipated clearance of Program Volume Delivered (PVD)

  6. False alarm for a rate below the recommended minimum for syringe size

  7. Incorrect bolus or loading dose time display

  8. Network configuration may affect pump communications

Some of the software malfunctions affect all versions of the pumps; however, some of the software malfunctions are limited to certain versions of the devices.

How GoldenbergLaw Can Help You

If you or a loved one suffered an injury due to the failure of a Medfusion 3500 and 4000 Syringe Infusion Pump, contact the Defective Medical Device Attorneys at GoldenbergLaw. Our law firm has more than 35 years of experience providing the Gold standard of advocacy to help our clients get justice. We have the expertise, experience, and compassion to help you. Contact us today for a free consultation.


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