—#157839

Product

Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111386
Affected lot / code info: Model No. 4000; Reference No. 4000-0101-51

Why it was recalled

Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.

Root cause (FDA determination)

Component design/selection

Action the firm took

The firm,Smiths Medical, sent an, "Urgent Medical Device Recall" Amendment Notice (amending the original August 2017) concerning invalid syringe size alarms on certain Medfusion Syringe Pump Model Series 3500 and 4000. The letter described the product, problem, actions to be to taken, and updated changes, as follows: 1. Locate the affected Medfusion Syringe Pump(s) by referring to the list of affected devices on the attached Urgent Medical Device Recall Notice Response Form. This form provides the specific serial number(s) your organization purchased. Each pump has a unique serial number which can be found on the label located on the bottom of the pump. If you have ten (10) or more affected pumps in your possession, please select one of the following repair options: a. Repair at your Facility: Contact Smiths Medical to schedule a technician to visit your facility and complete the necessary repairs onsite. b. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. c. NEW OPTION - Biomedical Department self-repair at your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. If you have nine (9) or fewer affected pumps in your possession: a. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Customer Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. b. NEW OPTION - Biomedical Department Self-Repair at Your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. To initi

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.

Timeline

Recall initiated: 2017-08-22
Terminated: 2025-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.