Events

Recall of Device Recall Medfusion 4000 Syringe Infusion Pumps

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
    66987
  • Event Risk Class
    Class 2
  • Event Number
    Z-0540-2014
  • Event Initiated Date
    2013-11-22
  • Event Date Posted
    2013-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124427
  • 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
    Smiths medical is conducting a recall involving all medfusion¿ 4000 syringe infusion pumps. smiths medical has identified an issue with electrical shorting at the ac power receptacle. shorting can occur when saline solution or other conductive fluids (e.G., potassium chloride) enter the ac power receptacle. when this happens, sparking and/ or flames, accompanied by smoke, may appear at the ac po.
  • Action
    Smiths Medical sent an "Urgent Medical Device Correction" letter dated November 22, 2013, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. All customers will be provided with instructions on inspection, cleaning, and prevention regarding this issue, for the continued safe and effective use of these pumps. Additionally, customers will be instructed to: 1. Return damaged pumps for servicing or damaged AC power cords for replacement to Smiths Medical. 2. Return the completed Confirmation Form to acknowledge receipt and understanding of the information provided in the Urgent Medical Device Correction letter, via fax or email, to Smiths Medical for processing. "The Instructions for preventing this issue", "Mitigations", Conclusions", " Action to be taken by the User", and "Transmission of this Urgent Medical Device Correction". The consignees were also asked to complete the "Urgent Medical Device confirmation Form" and fax it to 1-800-237-8033 or by sending an electronic copy via e-mail to medfusion4000nov2013@smiths-medical.com. For questions regarding this information, consignees should contact their local Sales Representative, Smiths Medical's Customer Service Department at 1-800-258-5361, or via e-mail at medfusion4000nov2013@smiths-medical.com. UPDATE: Consignees were sent a follow-up letter dated 13 January 2014 from the one dated November 22, 2013. The letter was addressed to Risk / Safety Managers, Biomedical Professionals, Clinicians who oversee the use of Medfusion Pumps, Distributors, and other users of these devices. The "Urgent Medical Device Recall" letter included Advise on Action to be Taken by the User. This included customers to have their Pumps undergo a free correction. The correction consists of the installation of a new AC power Receptacle seal. Smith Medical provided options for completing the correction process which included: 1) Consignees were a

Device

Device Recall Medfusion 4000 Syringe Infusion Pumps
  • Model / Serial
    All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.
  • Product Description
    Medfusion¿ 4000 Syringe Infusion Pumps || Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA