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U.S. Department of Health and Human Services

Class 2 Device Recall MEDFUSION SYRINGE INFUSION PUMP,

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  Class 2 Device Recall MEDFUSION SYRINGE INFUSION PUMP, see related information
Date Initiated by Firm June 22, 2010
Date Posted August 02, 2010
Recall Status1 Terminated 3 on April 17, 2012
Recall Number Z-2121-2010
Recall Event ID 56063
510(K)Number K040899  
Product Classification Infusion pump. - Product Code FRN
Product MEDFUSION¿ SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion¿ Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Code Information All Medfusion¿ Syringe Infusion Pumps, Models 3010 and 3010a, with Software Versions 2.0.2, 2.0.3. or 2.0.4
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-628-7280
Manufacturer Reason
for Recall		 Smiths Medical is conducting a correction of Medfusion¿ Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery  if the syringe is over-filled. Smiths Medical has received no reports of serious patient in
FDA Determined
Cause 2		 Software design
Action Consignees were sent on 6/22/10 a Smith Medical "Urgent Medical Device Correction Notice', dated June 11, 2010. The letter was addressed to Dear Risk/ Safety Managers, Distributors, Clinical/ Biomedical Engineering, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists; and Nursing, Pharmacy,and Anesthesia Professionals. The letter described the problem and product involved. It provided Advise on Action to be Taken by the User which included to 1) Determine the software version of their Medfusion pump 2. Complete and return the Confirmation Form 3. Return the completed Software Update Test Form 4. If unable or unwilling to perform the software upgrade they provided information for returning the pumps to Smiths Medical for the upgrade. For further information please contact Smiths Medical at 651-628-7280.
Quantity in Commerce 4816
Distribution Worldwide Distribution: AL, AK, AZ, AR, CA,CO, CT, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI. and countries of CANADA, MEXICO, NEW ZEALAND, BRASIL, HONG KONG, and GREAT BRITAIN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDEX, INC.
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