FDA Medical Device Recall

Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions

Please be aware, this recall is a correction, not a product removal.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

KCER Release Date: February 14, 2024

To: KCER Distribution list- including ESRD Network EDs and QIDs

Recalled Product 

• Product Names: Medfusion syringe pump

• Product Codes: FRN

• Model Numbers: Model 4000 syringe pump

• Distribution Dates: November 16, 2010 to July 28, 2023

• Devices Recalled in the U.S.: 50,743

• Date Initiated by Firm: December 19, 2023

Device Use

The Medfusion Model 4000 Syringe Infusion Pump is designed for precise control of infusion rates, making it suitable for administering fluids such as blood, lipids, drugs, antibiotics, and therapeutic fluids. It accommodates various delivery routes, including arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral. The pump supports delivery modes like continuous, volume/time, mass, body weight, intermittent, and bolus. It is applicable in critical care, anesthesia, neonatal and pediatric settings, or any healthcare environment where clinician monitoring, or supervision of the syringe infusion pump is feasible.

Reason for Recall

Smiths Medical ASD Inc. is recalling Medfusion model 4000 syringe pump due to issues associated with earlier software versions of the medical pump. Issues associated with earlier software versions of the medical pump may affect the alarm system, the pump, the control screen, and other parts of the pump. If undetected issues are present in the device, there is the potential that the device may fail and result in delay or interruption a therapy, or the device may fail to deliver the therapy per the programmed setting.

There have been 1 reported injury and no deaths related to this issue.

Who May be Affected

• Health care providers that use Medfusion Model 4000 Syringe Pumps

• People, especially vulnerable patients, such as those in the Neonatal Intensive Care unit (NICU) and Cardiac Intensive Care Unit (CICU) who are treated with the Medfusion Model 4000 Syringe Pump.

What to Do

On December 19, 2023, Smiths Medical sent an Urgent Medical Device Correction letter.

The letter requested customers to:

• Locate all affected pumps and ensure all users of these devices are immediately made aware of this notification and proposed mitigations.

• Confirm all pumps have the most recent Medfusion software installed.

• Complete the response form provided and return to smithmedical6114@sedgwick.com within ten days of receipt of this letter.

Contact Information

Customers in the U.S. with questions about this recall should contact Smiths Medical at 1-(866)-216-8806.

Full List of Affected Devices

Medfusion syringe pumps, with the following software versions before, may have the following issues:

• Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2)

• Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2),

• Incorrect Critical Data Failure Alarm,

• Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2),

• Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2),

• Volume Limit Before Bolus/Loading Dose Complete (v1.1.2),

• Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1),

• Depleted Battery Alarm (All versions previous to v1.6.5),

• Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4),

• PharmGuard Server Password (v2.3, v2.4, v2.5).

Additional Resources: 

• Medical Device Recall Database Entry

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.