Smiths Medical has recalled Medfusion 3500 and 4000 Syringe Pumps due to the risk of medication delivery error. The FDA considers this as a Class I recall. Continue reading to discover the details of this recall, who it affects, and what to do if you are an affected customer.
What is the Smiths Medical Medfusion Syringe Pump?
The Smiths Medical Medfusion Syringe Pump delivers blood, prescribed drugs, blood products, and other fluids into the patient’s body in a controlled manner. They are used in the pediatric and neonatal populations as well as in operating rooms and intensive care units for adults.
What is the recalled product?
The following are the recalled products by Smiths Medical: Medfusion Syringe Pumps Model 3500, firmware version 6.0.0 Models 3500-0600-00, -01, -249, -51, -82, Model 4000, firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0 Models 4000-0105-249, -50, -51, -78, 4000-0106-00, -01, -231, Manufacturing Dates: 5/2002 to present, Distribution Dates: 11/1/2013 to present, Devices Recalled in the U.S.: 46,395, Date Initiated by Firm: June 26, 2020.
What should I do if I am an affected customer?
Smiths Medical is recalling versions of the Medfusion 2500 and 4000 Syring Pumps due to software errors. These errors may lead to over-delivery or under-delivery of fluids or medication. Over or under-delivery may be a result if this specific sequence of events is to occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted. Serious adverse health consequences including death may be caused by the use of the affected syringe pumps. Smiths Medical sent an Urgent Medical Device Recall notice with instructions on what to do with affected devices:
Locate all Medfusion® 3500 and 4000 Syringe Pumps in possession and verify the firmware version to determine if the pump(s) is impacted by this notice.
Ensure all personnel who may utilize the pump are aware of this recall.
For any reason, when a bolus or loading dose delivery is interrupted, cancel the bolus or loading dose and begin a new infusion to avoid potential inappropriate delivery.
Complete and return the response form attached to the notice and email it to Smiths Medical at fieldactions@smiths-
medical.com within 10 days of receipt. Distributors share the notification with customers who have received the affected product and ask each customer to complete the response form contained in the notice and return to back to the distributor.
There have been four complaints regarding this device issue. There has been one serious injury. There have been no deaths. The FDA has classified this as a Class I recall, meaning these devices may cause serious injuries or death. Those that may be affected include health care providers using the affected pumps and patients who receive fluids or medications delivered by the affected pumps.
CONTACT OUR EXPERIENCED TEXAS FIRM
Brock & Goetzmann has significant experience representing victims of defective medical devices in the Dallas-Fort Worth area. If you have been impacted in any way by a defective medical device, preserve the evidence and call us to investigate. Contact our experienced Texas firm today to schedule your initial consultation.
