Smiths Medical Recalls Medfusion Model 3500 Syringe Pump

Smiths Medical ASD recently announced the recall of its Medfusion Model 3500 syringe pump due to issues associated with earlier software versions.

The Medfusion Model 3500 syringe pump is designed for precision control of infusion rates and is suitable to use in administering fluids like blood, lipids, drugs, antibiotics, and therapeutic fluids. Accommodating 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.

Recalled as a correction and not a product removal, the company said the device’s reported issues pertained to earlier software versions. Problems with the software include the potential for a high-priority alarm for delivery during motor not running, the device restarting infusion with incorrect parameters, “screen lock problems, interruptions in bolus or loading dose delivery, incorrect display of bolus/loading dose information, doses falling below the minimum recommended rate, motor rate errors, incorrect recall of last settings, corrupt configurations, auto lock issues, and problems with the toolbox configuration loading dose time values,” according to the recall notice posted by FDA.

When initially notifying the public on Dec. 19, 2023, or the issues in an Urgent Medical Device Correction letter, Smiths Medical requested that customers locate all affected pumps and ensure that all users of the device were aware of the notification and proposed mitigations detailed by the company. Additionally, customers were to confirm that all pumps in use were updated to the most recent Medfusion software, which the company said fixed the issues noted in the recall.

The recall notice disclosed that there is one reported injury and no deaths related to the issue.

This is not the first time the company has been on the wrong end of a recall in recent years in relation to its syringe pumps. In February last year, a similar warning was issued about more than 50,000 Smiths Medical Medfusion 4000 syringe pumps, citing earlier software version issues.

FDA categorized the recalls for both the model 3500 and 4000 as Class I at the beginning of February.