The FDA has issued a Class I recall of certain Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 manufactured by Smiths Medical ASD, Inc. because the firmware could potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy which may lead to serious injury, adverse events, or death. Smiths Medical has received 74 complaints related to the software update. No injuries or deaths have been reported.
Class I recall is the most serious type of recall: use of these devices may cause serious injuries or death.
Syringe pumps are primarily used in the neonatal and pediatric populations and in operating rooms and intensive care units for the adult population. The Smiths Medical ASD Medfusion 4000 Syringe Pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner.
The affected Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 are model numbers 4000-0107-01 and 4000-0106-01 that were manufactured on June 25, 2019 and distributed from September 27, 2019 to October 31, 2019. The total number of recalled units in the United States is 627.
The FDA stated in its medical device recall notice: “On October 28, 2019, Smiths Medical sent a Recall Notice to customers informing them of the affected models and instructing them to immediately return all affected products. The Recall Notice from Smiths Medical advised customers to locate all Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 in their possession.”
Medfusion® 4000 Syringe Pump
Smiths Medical ASD, Inc. states on its website: “Syringe infusion pumps are used to deliver small doses of medication from a variety of syringe sizes in acute care settings. The Medfusion® 4000 syringe pump is an intuitive system that helps confirm your critical decisions by thinking with you about infusion accuracy and safety. The wireless syringe pump is recognized for safe, accurate medication delivery to patients in the pediatric and neonatal intensive care units, adult critical care unit and the operating room … The reliable choice of the country’s best children’s hospitals, the Medfusion® syringe infusion pump is used by most hospitals on the U.S. News & World Report Children’s Hospital Honor Roll … The Pharmguard® Server Software closes the CQI loop by providing customizable and actionable reports for promoting improved patient outcomes … PharmGuard® Medication Safety Software helps reduce pump programming errors and associated adverse drug events by encouraging the use of drug libraries with hard and soft limits.”
Smith Medical states on its website that it is “a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world’s healthcare markets. Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for support in managing chronic illness.”
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