On August 25, 2020, Smiths Medical recalled several versions of its Medfusion 3500 and 4000 Syringe Pumps due to software problems that could lead to medication delivery errors.
The Medfusion Syringe Pumps are portable devices primarily found in children’s hospitals and neonatal intensive-care units, in addition to operating rooms and adult critical care units. When working as intended, the pumps reliably deliver blood, blood products, prescription drugs, and other fluids into a patient’s body in a slowed, controlled manner. However, according to an FDA announcement, Smiths Medical Medfusion Syringe Pumps have been reported to suffer software malfunctions. These malfunctions can cause the devices to over- or under- deliver fluids or medication, which could be fatal.
There has already been at least one serious injury reported with respect to the pumps. As such, the FDA has identified the recall as a Class I recall, which is the most serious type and denotes that use of these devices may cause serious injuries or death. The recall is also expansive. It affects nearly 50,000 devices distributed in the United States between 2013 and 2020.
This is not the first action the FDA has taken in regard to Smiths Medical’s Syringe Pumps. In December 2019, the FDA announced a recall of the Medfusion 4000 Syringe Pumps due to another software issue that could cause their low battery alarms to stop working. This could lead to an interruption in the transportation of fluids and medication, and potentially serious injury or death.
If you or a loved one has suffered serious injuries or died at a hospital that you suspect could be attributed to the over- or under- delivery of fluids or medication during an infusion, contact the Cincinnati product liability attorneys at Burg Simpson’s Ohio office today. Our experienced lineup of lawyers has a storied history of fighting dangerous medical device manufacturers who refuse to take responsibility for the harm they cause. They are here to help you. Call 513-852-5600 or fill out our contact form for a FREE no-obligation consultation today.