Events

Recall of Device Recall Medfusion Syringe Pump, 4000 Series

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77761
  • Event Risk Class
    Class 2
  • Event Number
    Z-0313-2018
  • Event Initiated Date
    2017-08-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157839
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion - Product Code FRN
  • Reason
    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.
  • Action
    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

Device

Device Recall Medfusion Syringe Pump, 4000 Series
  • Model / Serial
    Model No. 4000; Reference No. 4000-0101-51
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Product Description
    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.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Manufacturer Address
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA