Medfusion Syringe Pump Recall Due to Medication Error Risks

Federal drug safety officials have announced a Class I recall for Medfusion syringe pumps, after the manufacturer identified a software defect that may allow certain devices to over or under deliver fluids and medications, posing a serious risk of serious adverse health consequences for patients.

The Medfusion Syringe Pump recall was announced after several reports of patients receiving incorrect fluid doses, including at least one serious injury.

The impacted devices are Smiths Medical Medfusion Syringe Pumps designed to deliver blood, blood products, prescribed drugs, and other fluids into a patient’s body in a controlled manner. The pumps are primarily used in the intensive care and operating room setting for neonatal, pediatric and adult populations.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

An investigation into the software defect discovered the pumps may over or under deliver fluids after a specific sequence of events. According to the discoveries a medication error may occur when a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted.

Officials warn this specific sequence of functions may cause incorrect dosing delivery, increasing a patients risk of serious adverse health consequences including death.

The recall includes Medfusion Syringe Pump Model 3500-0600-00, -01, -249, -51, -82 with firmware version 6.0.0, and Model 4000-0105-249, -50, -51, -78, 4000-0106-00, -01, -231 with firmware version 1.5.0, 1.5.1, 1.6.0, 1.6.1, 1.7.0.

Approximately 46,395 recalled devices were manufactured by Smith Medical Inc. of Minneapolis, Minnesota from November 1, 2013 through June 22, 2020 and were distributed for sale to hospitals and medical facilities throughout the United States.

Smith Medical sent an Urgent Medical Device Recall notice on June 26, instructing customers to verify the firmware version of the Medfusion® 3500 and 4000 Syringe Pumps in their possession. Physicians using the impacted models are being instructed to cancel the bolus or loading dose and begin a new infusion in the event of a bolus or loading dose delivery interruption.

The FDA has classified the recall a Class I recall, meaning there is a reasonable probability that the use of the product will cause serious adverse health consequences or death.

Customers are being asked to complete and return the response form included in the medical device notice, and to ensure all personnel who utilize the pumps are aware of the recall.


Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal
BioZorb Lawsuit Alleges Breast Tissue Marker Failed, Requiring Surgical Removal (Posted yesterday)

A BioZorb lawsuit has been filed by several breast cancer survivors after the BioZorb implants moved out of place and failed to dissolve int he body, requiring surgical removal.

Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October
Fairness Hearing For Philips CPAP Recall Medical Monitoring Settlement Set for October (Posted yesterday)

A U.S. District Court judge has scheduled a fairness hearing for October in order to determine whether final approval should be granted to a $25 million Philips CPAP recall settlement agreement, which would pay former users $25 million to pay for future medical monitoring needs.