—#124427

Product

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K111386
Affected lot / code info: All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 1265 Grey Fox Rd, Saint Paul, Minnesota 55112-6929

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-11-22
Posted by FDA: 2013-12-19
Terminated: 2015-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124427. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.