—#203009

Product

Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K040899
Affected lot / code info: UDI/DI 10610586032325, All serial numbers

Why it was recalled

A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Smiths Medical sent an URGENT MEDICAL DEVICE CORRECTION notice to its direct consignees on 08/16/2023 by traceable mailing. The notice explained the issue, potential risk to the patient, and requested the following actions be taken: Customer Required Actions 1. Locate all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Ensure all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession have undergone all tests in the Annual Maintenance List including the new Force Sensor Check within the past 12 months, including new pumps that have not yet undergone annual maintenance. 3. Complete and return the attached Response Form to smithsmedical6995@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 4. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical6995@sedgwick.com

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2023-08-16
Posted by FDA: 2023-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203009. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.